A report released by the Leonard Davis Institute of Health Economics at the University of Pennsylvania has documented that low-nicotine and very low-nicotine cigarettes may increase carbon monoxide exposure among smokers and thus may present a greater health risk.
The report reviews the results of studies which evaluated Quest cigarettes - a product which uses genetically modified tobacco to reduce nicotine levels. In the studies, cigarettes with nicotine yields of 0.6, 0.3 and 0.05 mg were compared.
The report first documented that smokers do compensate by increasing their puff volume when smoking very-low nicotine cigarettes.
More importantly, the report documented that among smokers who do compensate by increasing their puff volume, there was an average of a 300% increase in carbon monoxide boost, indicating greatly increased exposure to carbon monoxide.
The report also documents that smokers tend to interpret low-nicotine claims as implying a safer cigarette. For example, 45% of smokers incorrectly inferred that Quest cigarettes are lower in tar. This despite the fact that the smokers were given information indicating clearly that Quest cigarettes do not reduce tar exposure.
The report concludes that the findings of these studies "provide behavioral and biochemical evidence for the possibility of compensatory smoking with a new low nicotine product, supporting the potential for increased, rather than reduced, harm."
"Second, they suggest that many smokers make false inferences about the relative safety of these cigarettes based on the product’s advertisement. If a new cigarette is misperceived as less harmful, it may attract smokers who would otherwise have quit or reduced smoking. Further research is needed to assess how Quest® cigarettes may divert smokers from more effective ways to reduce their harm from tobacco, including trying to quit smoking."
The Rest of the Story
These findings underscore the absurdity of public health groups' support for the proposed FDA tobacco legislation. They document that there is in fact no scientific basis to believe that reducing levels of nicotine or other specific constituents in cigarettes could or would produce a safer cigarette. More importantly, they demonstrate that substantial harm to the public's health would be done by requiring cigarette companies to lower nicotine levels or levels of other specific toxins. Not only would this likely result in increased exposure to other harmful constituents in the smoke, but it would also mislead smokers into thinking that cigarettes are safer, thus diverting smokers from more effective ways of reducing the harm from tobacco, namely: quitting.
It is important to note that a cigarette with 0.05 mg of nicotine is essentially a nicotine-free cigarette (in fact, that's how Quest is being marketed). However, such a cigarette was documented to increase toxic carbon monoxide exposure by 300% in smokers who compensate by increasing their puff volume in response to the reduced nicotine yield.
It is also important to note that these studies grossly underestimate the degree of compensation that would occur in actual life. These studies ask smokers to simply try Quest on one occasion. Compensation is a process that takes a period of time. If smokers were to smoke Quest for a period of weeks or months, it is likely that not only would their puff volume increase, but their cigarette consumption would increase as well.
Given the increased carbon monoxide delivery of these nicotine-free cigarettes, it would not be surprising to see clinical harm done to smokers if the effects of Quest were studied for any substantial length of time.
Clearly, it would be inappropriate for Vector Tobacco to market Quest as a safer cigarette. If Vector made any claims that Quest was a safer cigarette, I can assure you that anti-smoking groups would immediately blast the company and call for FTC to ban that advertising. I'm sure that the Campaign for Tobacco-Free Kids would be at the front of the pack (as they should).
The insanity of the proposed FDA regulatory scheme is that this is precisely what the Campaign for Tobacco-Free Kids now wants the FDA to do. And it is a pipedream to think that the FDA would do something as substantial as requiring a nicotine-free cigarette. This is in fact the best case scenario.
The rest of the story is that in actual practice, as documented by scientific evidence, even a 0.05 mg (nicotine-free) cigarette has been documented not only not to be safer, but to actually pose an increased potential harm to smokers by virtue of a drastically increased delivery of carbon monoxide to smokers who compensate in order to try to maintain constant levels of nicotine dosage.
Moreover, smokers misinterpret the rather clear marketing information and infer that the product reduces tar delivery and is a safer product. This would likely result in increased cigarette consumption and divert smokers from quitting.
Essentially, the FDA legislation would make one major change: instead of the cigarette companies defrauding the American public by making them incorrectly think that extremely low-nicotine, low-nicotine, and low-tar cigarettes are safer, it would be our own government. And in fact, that would essentially be their mandate.
It is truly beyond me how any anti-smoking or public health group could support this legislation.
One thing is for certain: the anti-smoking groups sure do not let the science get in their way.
Tuesday, March 20, 2007
Monday, March 19, 2007
Smoking is a Sign of Weakness, Suggests Anti-Smoking Group
As quoted in a recent newspaper article, the national anti-smoking group Action on Smoking and Health (ASH) has suggested that smoking is a sign of weakness and lack of will and determination, not befitting of a president. ASH executive director John Banzhaf is quoted in the St. Petersburg Times in response to the presidential campaign of Senator Barack Obama - a smoker who is attempting to quit smoking: "For many people, smoking is seen as a sign of weakness and lack of willpower. A presidential candidate would not want to be seen as lacking strong will or lacking determination."
The Rest of the Story
Funny that. Coming from a group that helped spearhead many of the lawsuits by smokers against the tobacco companies. A key element of these cases is that smoking is an addiction, and that quitting is not as simple as just having willpower. In fact, the tobacco company defense in these cases has been based on convincing juries that smoking is a sign of weakness and lack of willpower. It's a good thing ASH didn't make this same statement prior to, and during the bulk of the tobacco cases. They would have destroyed their own argument.
I find it unfortunate that a national anti-smoking group is helping to reinforce the image of the smoker as a weak creature who lacks willpower and determination. And that such a group is suggesting that smoking is inappropriate for a presidential candidate because it displays a lack of willpower and determination that could affect the candidate's qualifications to serve as president.
The suggestion that smokers simply lack willpower and determination shows a profound lack of understanding of the concept of addiction. And it contributes to obscuring the public's appreciation of the addictive nature of smoking.
Interestingly, you don't hear ASH talking about how being fat represents a lack of willpower and determination. Or how having type 2 diabetes represents a lack of willpower and determination (since it can be controlled almost completely by weight loss). Or how having mild hypertension represents a lack of willpower and determination (as it can almost always be controlled completely by dietary changes). Or how drinking coffee daily is a sign of weakness.
I haven't heard any suggestion recently about how a presidential candidate should quit drinking coffee before running so as not to be perceived as being weak and therefore not an effective potential leader.
Frankly, I don't see how the (lawful) personal health behavior of a presidential candidate has any relevance to his or her qualifications for the office of president. But more importantly, to suggest that smoking is a sign of weakness sounds like a cheap jab, possibly motivated by hatred of smokers. It is also a sign of class discrimination, since we don't talk the same way about poor health behaviors in which sub-populations of higher education and income status tend to engage.
Smoking is not a sign of weakness, any more than being fat or sitting around watching four straight days of basketball on television (yes, I'm guilty) are signs of weakness.
Let's get our message straight, shan't we? Is smoking a supreme form of weakness and lack of willpower and determination, or is it one of life's addictions? At this point, I hardly care which side ASH takes. But don't suggest one thing to the public (it's a sign of weakness and lack of willpower and determination) and then expect juries throughout the country to force tobacco companies to pay billions of dollars to smokers because they were addicted and could not quit smoking even after they became aware of its adverse health consequences. Isn't it that they were just weak?
The Rest of the Story
Funny that. Coming from a group that helped spearhead many of the lawsuits by smokers against the tobacco companies. A key element of these cases is that smoking is an addiction, and that quitting is not as simple as just having willpower. In fact, the tobacco company defense in these cases has been based on convincing juries that smoking is a sign of weakness and lack of willpower. It's a good thing ASH didn't make this same statement prior to, and during the bulk of the tobacco cases. They would have destroyed their own argument.
I find it unfortunate that a national anti-smoking group is helping to reinforce the image of the smoker as a weak creature who lacks willpower and determination. And that such a group is suggesting that smoking is inappropriate for a presidential candidate because it displays a lack of willpower and determination that could affect the candidate's qualifications to serve as president.
The suggestion that smokers simply lack willpower and determination shows a profound lack of understanding of the concept of addiction. And it contributes to obscuring the public's appreciation of the addictive nature of smoking.
Interestingly, you don't hear ASH talking about how being fat represents a lack of willpower and determination. Or how having type 2 diabetes represents a lack of willpower and determination (since it can be controlled almost completely by weight loss). Or how having mild hypertension represents a lack of willpower and determination (as it can almost always be controlled completely by dietary changes). Or how drinking coffee daily is a sign of weakness.
I haven't heard any suggestion recently about how a presidential candidate should quit drinking coffee before running so as not to be perceived as being weak and therefore not an effective potential leader.
Frankly, I don't see how the (lawful) personal health behavior of a presidential candidate has any relevance to his or her qualifications for the office of president. But more importantly, to suggest that smoking is a sign of weakness sounds like a cheap jab, possibly motivated by hatred of smokers. It is also a sign of class discrimination, since we don't talk the same way about poor health behaviors in which sub-populations of higher education and income status tend to engage.
Smoking is not a sign of weakness, any more than being fat or sitting around watching four straight days of basketball on television (yes, I'm guilty) are signs of weakness.
Let's get our message straight, shan't we? Is smoking a supreme form of weakness and lack of willpower and determination, or is it one of life's addictions? At this point, I hardly care which side ASH takes. But don't suggest one thing to the public (it's a sign of weakness and lack of willpower and determination) and then expect juries throughout the country to force tobacco companies to pay billions of dollars to smokers because they were addicted and could not quit smoking even after they became aware of its adverse health consequences. Isn't it that they were just weak?
Friday, March 16, 2007
Is Receiving a Placebo the Same Thing as Trying to Quit Cold Turkey? The Limitations of NRT Clinical Trials
In a must-read commentary for all tobacco control practitioners, John Polito explains in easy-to-understand terms why there is such a discrepancy between clinical trial research - which has shown a clear benefit of nicotine replacement therapy (NRT) and other pharmaceutical smoking cessation aids - and population-based research, which demonstrates that NRT is not particularly effective and that cold turkey quitting remains the most effective cessation method.
Polito explains that NRT clinical trials essentially equate receiving a placebo with quitting cold turkey. In other words, in comparing the use of NRT to quitting without pharmaceutical aids, these clinical trials provide nicotine replacement medication to some subjects and a complete dud of a pill to other subjects. It is quite clear to many receiving the placebo that they are taking a dud, since the physiologic effects of nicotine are quite easy to detect. Subjects who are disappointed that they are receiving placebo are discouraged and more likely to return to smoking, simply because of their disappointment that they were not randomized to receive a real medication.
In a brilliant exposition of the limitations of NRT clinical trial research, Polito writes: "The only way to have honest comparisons is to invite and fairly service the nicotine dependency recovery needs of those having an expectation of abruptly ending all nicotine use. To experience the current study format farce in all its glory we'd need to actively recruit smokers who want to quit cold turkey and then randomly assign half to wear a patch. If that sounds strange, remember it is just the mirror image of the clinical trials done to date."
In other words, NRT clinical trials are essentially comparing smoking cessation rates among those who are highly motivated to quit and receive nicotine with cessation rates among those who are highly motivated to quit and then given the disappointment of not receiving the nicotine that they were hoping for.
The Rest of the Story
This explains why the clinical trials have shown a benefit for NRT, while population-based studies, which Polito reviews, have confirmed that cold turkey quitting remains the most effective cessation method. For example, as Dr. John Pierce of the University of California San Diego concluded, the use of NRT "is not associated with any increase in successful quitting in the population."
Interestingly, Pierce was viciously attacked, not for shoddy science but for even daring to suggest that NRT may not be effective. Tobacco control is so firmly entrenched in the hands (and money) of Big Pharma that it simply does not want to hear that pharmaceutical smoking cessation aids are not the panacea that the public has been told they are.
The attacks on Dr. Pierce are not a surprise to me anymore, as I have learned from my own experience that dissent is not allowed in tobacco control and that one cannot challenge the established wisdom of the movement without being personally attacked. The movement is unable to respond substantively to critics, and thus resorts to ad-hominem attacks.
The truth is, however, that Pierce's study was not in any way unique. It simply confirms the results of at least 7 other population-based studies which also found that NRT offers no long-term abstinence benefits when compared to quitting cold turkey.
Fortunately, the limitations of the NRT clinical trials and the pharmaceutical ties of those who are setting national smoking cessation treatment guidelines are starting to be publicly exposed. A February 8 article in the Wall Street Journal noted the financial conflict of interest of the chair of the federal panel that is revising the smoking cessation guidelines:
"Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies. Now debate is growing about that evidence, and about who should be entrusted to interpret it. Some public-health officials say industry-funded doctors are ignoring other studies that suggest cold turkey is just as effective or even superior to nicotine patches and other pharmaceuticals over the long run, not to mention cheaper. "
"The Public Health Service, part of the Department of Health and Human Services, issued guidelines in 2000 calling for smokers to use nicotine patches, gums and other pharmaceutical aids to quit, with a few exceptions such as pregnant women. Dr. Fiore, a University of Wisconsin professor of medicine, headed the 18-member panel that created those guidelines. He and at least eight others on it had ties to the makers of stop-smoking products."
My own opinion, based on my years of experience in the field, is that the almost singular focus on NRT and other pharmaceutical treatments for smoking dependence are more of an impediment to smokers quitting than a help. This focus is obscuring the real problem - which is that smokers must be highly motivated if they are going to quit successfully and long-term.
In other words, smokers are not going to quit unless they really want to quit. You can try cold turkey, with NRT, or with accupuncture or hypnosis, but if you are not highly motivated to quit and do not really feel a deep, emotional desire to rid yourself of the addiction, it's not going to happen. In my experience, the desire to quit cold turkey indicates a much higher level of motivation to quit than simply the desire to take a drug.
Our smoking cessation plan should focus on motivating smokers to quit, not on getting doctors to prescribe pharmaceutical products and making smokers think that quitting smoking is as easy as popping a pill or applying a patch.
This past Tuesday, Ken Millstone of the Columbia News Service highlighted John Polito's and my concerns that cold turkey quitting is being slighted because of the tobacco control movement's singular pre-occupation with pharmaceutical cessation treatment.
"With nicotine replacement therapy, 'the levels of long-term success are dismal,' said Dr. Michael Siegel, a physician and professor at Boston University's School of Public Health. 'More important, I think the role of nicotine replacement therapy as part of a national policy to address smoking cessation has been over emphasized.... Quitting cold turkey has been the most effective way of quitting smoking.'"
Countering my comments and those of John Polito was Dr. Saul Shiffman, "a professor of psychology at the University of Pittsburgh who has studied smoking cessation for 30 years."
Interestingly, what the article does not disclose is that Shiffman has an enormous financial conflict of interest. Far from merely being a professor (like I am), he is also a senior scientific advisor for Pinney Associates, a for-profit business which is funded primarily by...
... you guessed it ------> pharmaceutical companies.
Dr. Shiffman is a consultant to GlaxoSmithKline, maker of NiQuitin, Nicoderm CQ, Nicabate, and Nicorette. He has been paid by GlaxoSmithKline to conduct research with them, and has received funding from the pharmaceutical company for this research. According to his disclosure in another article, he "also has an interest in a new smoking cessation product."
If I'm interpreting this correctly, not only has Dr. Shiffman been funded by GlaxoSmithKline or his research and received consulting income from GlaxoSmithKline, and not only does his company consult primarily for pharmaceutical companies, but he actually has his own financial interest in a new smoking cessation pharmaceutical product.
If I had such extensive financial interests in smoking cessation pharmaceutical products, I'm sure I would also have a much more positive appraisal of the effectiveness and role of these products.
Polito explains that NRT clinical trials essentially equate receiving a placebo with quitting cold turkey. In other words, in comparing the use of NRT to quitting without pharmaceutical aids, these clinical trials provide nicotine replacement medication to some subjects and a complete dud of a pill to other subjects. It is quite clear to many receiving the placebo that they are taking a dud, since the physiologic effects of nicotine are quite easy to detect. Subjects who are disappointed that they are receiving placebo are discouraged and more likely to return to smoking, simply because of their disappointment that they were not randomized to receive a real medication.
In a brilliant exposition of the limitations of NRT clinical trial research, Polito writes: "The only way to have honest comparisons is to invite and fairly service the nicotine dependency recovery needs of those having an expectation of abruptly ending all nicotine use. To experience the current study format farce in all its glory we'd need to actively recruit smokers who want to quit cold turkey and then randomly assign half to wear a patch. If that sounds strange, remember it is just the mirror image of the clinical trials done to date."
In other words, NRT clinical trials are essentially comparing smoking cessation rates among those who are highly motivated to quit and receive nicotine with cessation rates among those who are highly motivated to quit and then given the disappointment of not receiving the nicotine that they were hoping for.
The Rest of the Story
This explains why the clinical trials have shown a benefit for NRT, while population-based studies, which Polito reviews, have confirmed that cold turkey quitting remains the most effective cessation method. For example, as Dr. John Pierce of the University of California San Diego concluded, the use of NRT "is not associated with any increase in successful quitting in the population."
Interestingly, Pierce was viciously attacked, not for shoddy science but for even daring to suggest that NRT may not be effective. Tobacco control is so firmly entrenched in the hands (and money) of Big Pharma that it simply does not want to hear that pharmaceutical smoking cessation aids are not the panacea that the public has been told they are.
The attacks on Dr. Pierce are not a surprise to me anymore, as I have learned from my own experience that dissent is not allowed in tobacco control and that one cannot challenge the established wisdom of the movement without being personally attacked. The movement is unable to respond substantively to critics, and thus resorts to ad-hominem attacks.
The truth is, however, that Pierce's study was not in any way unique. It simply confirms the results of at least 7 other population-based studies which also found that NRT offers no long-term abstinence benefits when compared to quitting cold turkey.
Fortunately, the limitations of the NRT clinical trials and the pharmaceutical ties of those who are setting national smoking cessation treatment guidelines are starting to be publicly exposed. A February 8 article in the Wall Street Journal noted the financial conflict of interest of the chair of the federal panel that is revising the smoking cessation guidelines:
"Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies. Now debate is growing about that evidence, and about who should be entrusted to interpret it. Some public-health officials say industry-funded doctors are ignoring other studies that suggest cold turkey is just as effective or even superior to nicotine patches and other pharmaceuticals over the long run, not to mention cheaper. "
"The Public Health Service, part of the Department of Health and Human Services, issued guidelines in 2000 calling for smokers to use nicotine patches, gums and other pharmaceutical aids to quit, with a few exceptions such as pregnant women. Dr. Fiore, a University of Wisconsin professor of medicine, headed the 18-member panel that created those guidelines. He and at least eight others on it had ties to the makers of stop-smoking products."
My own opinion, based on my years of experience in the field, is that the almost singular focus on NRT and other pharmaceutical treatments for smoking dependence are more of an impediment to smokers quitting than a help. This focus is obscuring the real problem - which is that smokers must be highly motivated if they are going to quit successfully and long-term.
In other words, smokers are not going to quit unless they really want to quit. You can try cold turkey, with NRT, or with accupuncture or hypnosis, but if you are not highly motivated to quit and do not really feel a deep, emotional desire to rid yourself of the addiction, it's not going to happen. In my experience, the desire to quit cold turkey indicates a much higher level of motivation to quit than simply the desire to take a drug.
Our smoking cessation plan should focus on motivating smokers to quit, not on getting doctors to prescribe pharmaceutical products and making smokers think that quitting smoking is as easy as popping a pill or applying a patch.
This past Tuesday, Ken Millstone of the Columbia News Service highlighted John Polito's and my concerns that cold turkey quitting is being slighted because of the tobacco control movement's singular pre-occupation with pharmaceutical cessation treatment.
"With nicotine replacement therapy, 'the levels of long-term success are dismal,' said Dr. Michael Siegel, a physician and professor at Boston University's School of Public Health. 'More important, I think the role of nicotine replacement therapy as part of a national policy to address smoking cessation has been over emphasized.... Quitting cold turkey has been the most effective way of quitting smoking.'"
Countering my comments and those of John Polito was Dr. Saul Shiffman, "a professor of psychology at the University of Pittsburgh who has studied smoking cessation for 30 years."
Interestingly, what the article does not disclose is that Shiffman has an enormous financial conflict of interest. Far from merely being a professor (like I am), he is also a senior scientific advisor for Pinney Associates, a for-profit business which is funded primarily by...
... you guessed it ------> pharmaceutical companies.
Dr. Shiffman is a consultant to GlaxoSmithKline, maker of NiQuitin, Nicoderm CQ, Nicabate, and Nicorette. He has been paid by GlaxoSmithKline to conduct research with them, and has received funding from the pharmaceutical company for this research. According to his disclosure in another article, he "also has an interest in a new smoking cessation product."
If I'm interpreting this correctly, not only has Dr. Shiffman been funded by GlaxoSmithKline or his research and received consulting income from GlaxoSmithKline, and not only does his company consult primarily for pharmaceutical companies, but he actually has his own financial interest in a new smoking cessation pharmaceutical product.
If I had such extensive financial interests in smoking cessation pharmaceutical products, I'm sure I would also have a much more positive appraisal of the effectiveness and role of these products.
Thursday, March 15, 2007
Santa Cruz County Bans the Mere Possession of Tobacco Products in Parks
According to an article on San Francisco's KRON web site, the Santa Cruz County Board of Supervisors voted Tuesday night to ban not only the use but the possession of tobacco products in any county parks. Anyone who lights up or chews smokeless tobacco would be subject to a $92 fine. And anyone who merely possesses cigarettes or smokeless tobacco would also be subject to the same $92 fine.
According to the article, the purpose of the ordinance is to reduce secondhand smoke exposure and to reduce the risk of fires: "Samuel [the parks director] says, 'Second-hand smoke is a known carcinogen. We believe our children deserve a clean, safe place to play.' ... The smoking ban applies to everyone and any type of tobacco, even smokeless. Officials say the idea is to keep the county's 30 parks free of second-hand smoke. Samuel expects the ban to reduce the number of park fires caused by smokers."
The Rest of the Story
If the purpose of the ordinance is to reduce secondhand smoke exposure and reduce the risk of fires, then why would it be necessary to outlaw the mere possession of tobacco products? And why would it be necessary to outlaw the use or possession of smokeless tobacco? So far as I am aware, smokeless tobacco produces no secondhand smoke and does not cause fires. What am I missing here?
Unless I'm missing something, it appears that there is some sort of ulterior motive that the County supervisors have in banning the mere possession of tobacco products in parks.
I'm not a smoker, but it is my sense that if you do smoke, you may likely carry a pack of cigarettes around with you. If you don't drive, and rely on public transportation or walk or ride a bike, then you are going to have that pack with you wherever you go. What this ordinance essentially means, then, is that you are basically not welcome in that park. You cannot enter the park with your cigarettes, even if you have no intention of lighting up, without risking a rather significant $92 fine.
It seems to me that treating tobacco products as such an illicit possession that you have to go undercover with to even enter a park is inappropriate. Moreover, it might even have the perverse effect of making tobacco use more appealing to adolescents, especially those who are rebellious. And isn't that pretty much all of them?
Combined with my earlier post about Belmont's proposed ban on smoking on all sidewalks and streets and its current plan to make permitting smoking in these places to be a criminal offense, I rest my case that the anti-smoking movement has lost its bearings and is going too far.
(Thanks to GreatScot for the tip.)
According to the article, the purpose of the ordinance is to reduce secondhand smoke exposure and to reduce the risk of fires: "Samuel [the parks director] says, 'Second-hand smoke is a known carcinogen. We believe our children deserve a clean, safe place to play.' ... The smoking ban applies to everyone and any type of tobacco, even smokeless. Officials say the idea is to keep the county's 30 parks free of second-hand smoke. Samuel expects the ban to reduce the number of park fires caused by smokers."
The Rest of the Story
If the purpose of the ordinance is to reduce secondhand smoke exposure and reduce the risk of fires, then why would it be necessary to outlaw the mere possession of tobacco products? And why would it be necessary to outlaw the use or possession of smokeless tobacco? So far as I am aware, smokeless tobacco produces no secondhand smoke and does not cause fires. What am I missing here?
Unless I'm missing something, it appears that there is some sort of ulterior motive that the County supervisors have in banning the mere possession of tobacco products in parks.
I'm not a smoker, but it is my sense that if you do smoke, you may likely carry a pack of cigarettes around with you. If you don't drive, and rely on public transportation or walk or ride a bike, then you are going to have that pack with you wherever you go. What this ordinance essentially means, then, is that you are basically not welcome in that park. You cannot enter the park with your cigarettes, even if you have no intention of lighting up, without risking a rather significant $92 fine.
It seems to me that treating tobacco products as such an illicit possession that you have to go undercover with to even enter a park is inappropriate. Moreover, it might even have the perverse effect of making tobacco use more appealing to adolescents, especially those who are rebellious. And isn't that pretty much all of them?
Combined with my earlier post about Belmont's proposed ban on smoking on all sidewalks and streets and its current plan to make permitting smoking in these places to be a criminal offense, I rest my case that the anti-smoking movement has lost its bearings and is going too far.
(Thanks to GreatScot for the tip.)
Proposed Belmont Smoking Ban Would Criminalize Citizens for Failing to Report People Smoking; Would Ban Smoking on All Streets and Sidewalks to Boot
Under the terms of a proposed smoking ban presented to the Belmont City Council on Tuesday evening, smoking would not only be banned on all city streets and sidewalks but citizens who fail to report smokers who they see smoking on those streets and sidewalks would be guilty of a crime - a misdemeanor.
Under section 3(a)(1) of the draft ordinance, smoking is prohibited in all public places, which by definition includes all streets and sidewalks.
Under section 10(e), "Causing, permitting, aiding, abetting, or concealing a violation of any provision of this article shall also constitute a violation of this article."
Under section 10(b), smoking in an area where it is prohibited represents a civil infraction, punishable by a fine. However, all other violations of the ordinance represent criminal offenses: "Other violations of this article constitute misdemeanors... ."
Thus, if a person permits or conceals a violation of the ordinance (i.e., someone smoking on a street or sidewalk), he or she has committed a criminal offense - a misdemeanor.
The Rest of the Story
I guess I don't want to visit Belmont any time soon. If I'm walking down the street and I see someone smoking and I fail to report it to the Belmont police, then I could be construed as permitting and/or concealing a violation of the smoking ordinance, and therefore I would be guilty of my first crime - a misdemeanor.
Imagine that - becoming a criminal simply by virtue of failing to report a person who is smoking on a sidewalk or in a street. Even if no one else is being exposed to that smoke and it is not causing any potential health problems.
Is this really what Belmont wants? To create a city where nonsmokers are guilty of a crime if they don't tattle on any smokers they see smoking in streets, on sidewalks, in parks, or any other outdoor public places?
I imagine that the law-abiding citizens of Belmont will be quite busy after this ordinance passes. Imagine the time it would take to report every person you see smoking. You might as well walk around with a clipboard all day and report to the police station before heading home for the night.
Now since aiding and abetting a violation of the ordinance is also a crime, does that not mean that if you give someone a cigarette to smoke on a street corner, you are guilty of a crime, since you have abetted and aided your fellow smoker in violating the ordinance?
Actually, if you witness someone smoking on a sidewalk and you fail to accost them and forcibly remove the cigarette from their mouth, are you not permitting a violation of the ordinance? Are you not then also guilty of committing a crime?
And say it's your own wife who is smoking on the street corner. If you don't immediately report her to the authorities, are you not concealing a violation of the ordinance, making you a criminal alongside her? Actually, correct that. She is not a criminal. Her offense is merely a civil one. She only need pay a small fine. You, however, are guilty of a misdemeanor, which could potentially carry far more severe penalties.
I can see the conversation between prison inmates now:
What are you in for?
Attempted murder. How about you?
Failing to rag on my wife for smoking in a deserted parking lot.
What if you are actually a smoker who is violating the ordinance, smoking on a street corner alongside another smoker? While you are only guilty of a minor civil violation for the smoking, you are guilty of a misdemeanor if you fail to report your friend's violation of the law.
This proposal goes way too far. Streets and sidewalks are where we want smokers to smoke: outside - and in areas where nonsmokers can quite easily avoid substantial smoke exposure. There is simply no health justification for such a sweeping ban on outdoor smoking.
Notwithstanding the claims of the Surgeon General and more than a hundred anti-smoking groups that even a brief exposure to secondhand smoke can cause heart disease, heart attacks, and instant death, there is no scientific evidence that smoking on streets and sidewalks causes any significant public health problem.
I hate to have to say it, but what Belmont is doing is starting to look like an all-out crusade against smokers, rather than a sincere attempt to protect nonsmokers against a severe and devastating public health hazard. Why else would you want to banish smokers from every street corner, parking lot, and sidewalk?
I'm afraid that the extremist actions being considered by policy makers in Belmont, and apparently supported wholeheartedly by anti-smoking groups, are going to threaten even the more reasonable and justified efforts elsewhere in the country to protect the public from substantial exposure to secondhand smoke. This kind of fanaticism is going to give anti-smoking groups a bad name. It is going to make us look like we are crazy and unreasonable.
Is it really worth risking the protection of bar, restaurant, and casino workers throughout the nation, who truly are suffering every day from high levels of secondhand smoke exposure, in order for the people of Belmont not to have to worry about a few wisps of smoke when they walk down the street?
The rest of the story is that if you want to keep your criminal record clean, do not go to Belmont. Or if you do, make sure to wear a bag over your head so that you cannot possibly see anyone smoking.
Under section 3(a)(1) of the draft ordinance, smoking is prohibited in all public places, which by definition includes all streets and sidewalks.
Under section 10(e), "Causing, permitting, aiding, abetting, or concealing a violation of any provision of this article shall also constitute a violation of this article."
Under section 10(b), smoking in an area where it is prohibited represents a civil infraction, punishable by a fine. However, all other violations of the ordinance represent criminal offenses: "Other violations of this article constitute misdemeanors... ."
Thus, if a person permits or conceals a violation of the ordinance (i.e., someone smoking on a street or sidewalk), he or she has committed a criminal offense - a misdemeanor.
The Rest of the Story
I guess I don't want to visit Belmont any time soon. If I'm walking down the street and I see someone smoking and I fail to report it to the Belmont police, then I could be construed as permitting and/or concealing a violation of the smoking ordinance, and therefore I would be guilty of my first crime - a misdemeanor.
Imagine that - becoming a criminal simply by virtue of failing to report a person who is smoking on a sidewalk or in a street. Even if no one else is being exposed to that smoke and it is not causing any potential health problems.
Is this really what Belmont wants? To create a city where nonsmokers are guilty of a crime if they don't tattle on any smokers they see smoking in streets, on sidewalks, in parks, or any other outdoor public places?
I imagine that the law-abiding citizens of Belmont will be quite busy after this ordinance passes. Imagine the time it would take to report every person you see smoking. You might as well walk around with a clipboard all day and report to the police station before heading home for the night.
Now since aiding and abetting a violation of the ordinance is also a crime, does that not mean that if you give someone a cigarette to smoke on a street corner, you are guilty of a crime, since you have abetted and aided your fellow smoker in violating the ordinance?
Actually, if you witness someone smoking on a sidewalk and you fail to accost them and forcibly remove the cigarette from their mouth, are you not permitting a violation of the ordinance? Are you not then also guilty of committing a crime?
And say it's your own wife who is smoking on the street corner. If you don't immediately report her to the authorities, are you not concealing a violation of the ordinance, making you a criminal alongside her? Actually, correct that. She is not a criminal. Her offense is merely a civil one. She only need pay a small fine. You, however, are guilty of a misdemeanor, which could potentially carry far more severe penalties.
I can see the conversation between prison inmates now:
What are you in for?
Attempted murder. How about you?
Failing to rag on my wife for smoking in a deserted parking lot.
What if you are actually a smoker who is violating the ordinance, smoking on a street corner alongside another smoker? While you are only guilty of a minor civil violation for the smoking, you are guilty of a misdemeanor if you fail to report your friend's violation of the law.
This proposal goes way too far. Streets and sidewalks are where we want smokers to smoke: outside - and in areas where nonsmokers can quite easily avoid substantial smoke exposure. There is simply no health justification for such a sweeping ban on outdoor smoking.
Notwithstanding the claims of the Surgeon General and more than a hundred anti-smoking groups that even a brief exposure to secondhand smoke can cause heart disease, heart attacks, and instant death, there is no scientific evidence that smoking on streets and sidewalks causes any significant public health problem.
I hate to have to say it, but what Belmont is doing is starting to look like an all-out crusade against smokers, rather than a sincere attempt to protect nonsmokers against a severe and devastating public health hazard. Why else would you want to banish smokers from every street corner, parking lot, and sidewalk?
I'm afraid that the extremist actions being considered by policy makers in Belmont, and apparently supported wholeheartedly by anti-smoking groups, are going to threaten even the more reasonable and justified efforts elsewhere in the country to protect the public from substantial exposure to secondhand smoke. This kind of fanaticism is going to give anti-smoking groups a bad name. It is going to make us look like we are crazy and unreasonable.
Is it really worth risking the protection of bar, restaurant, and casino workers throughout the nation, who truly are suffering every day from high levels of secondhand smoke exposure, in order for the people of Belmont not to have to worry about a few wisps of smoke when they walk down the street?
The rest of the story is that if you want to keep your criminal record clean, do not go to Belmont. Or if you do, make sure to wear a bag over your head so that you cannot possibly see anyone smoking.
Wednesday, March 14, 2007
Wall Street Journal Editorial Provides Blistering Review of Proposed FDA Tobacco Legislation
An editorial in Tuesday's Wall Street Journal blasts the proposed FDA tobacco legislation being supported by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, American Lung Association, American Medical Association, and many other health groups, calling it the "Marlboro Preservation Act" and arguing that it would help Big Tobacco rather than hurt the cigarette companies and protect the public's health.
The editorial points out that Wall Street investment companies have hailed the legislation as a winning proposition for Big Tobacco. Morgan Stanley noted that the legislation would provide a strong defense for the tobacco companies in litigation, giving them virtual immunity. Citigroup went so far as to conclude that the legislation "would actually help the major cigarette manufacturers since it would entrench their position further allowing them to maintain market share or increase it."
The editorial also notes that by asking the FDA to reduce nicotine levels, the public's health may actually be harmed, since smokers will inhale more deeply or smoke more in order to get the same amount of nicotine: "An FDA diktat to reduce nicotine in cigarettes could have the perverse effect of inducing the 40 million or so current smokers to light up more often to get their nicotine 'high.' That might mean more cigarette sales and more deaths."
"These low-nicotine cigarettes would be similar to 'light' cigarettes, which health groups have long argued and the courts have ruled are no safer than high-nicotine smokes. 'The FDA would be essentially repeating the fraud the tobacco companies were recently found guilty of,' says Michael Siegel of the Boston University school of public health."
The editorial suggests that the health groups are actually assisting Big Tobacco by promoting this legislation and notes that this would not be the first time that policy makers and health advocates "assisted Big Tobacco in the name of opposing it," citing the Master Settlement Agreement as another example.
The editorial points out that Wall Street investment companies have hailed the legislation as a winning proposition for Big Tobacco. Morgan Stanley noted that the legislation would provide a strong defense for the tobacco companies in litigation, giving them virtual immunity. Citigroup went so far as to conclude that the legislation "would actually help the major cigarette manufacturers since it would entrench their position further allowing them to maintain market share or increase it."
The editorial also notes that by asking the FDA to reduce nicotine levels, the public's health may actually be harmed, since smokers will inhale more deeply or smoke more in order to get the same amount of nicotine: "An FDA diktat to reduce nicotine in cigarettes could have the perverse effect of inducing the 40 million or so current smokers to light up more often to get their nicotine 'high.' That might mean more cigarette sales and more deaths."
"These low-nicotine cigarettes would be similar to 'light' cigarettes, which health groups have long argued and the courts have ruled are no safer than high-nicotine smokes. 'The FDA would be essentially repeating the fraud the tobacco companies were recently found guilty of,' says Michael Siegel of the Boston University school of public health."
The editorial suggests that the health groups are actually assisting Big Tobacco by promoting this legislation and notes that this would not be the first time that policy makers and health advocates "assisted Big Tobacco in the name of opposing it," citing the Master Settlement Agreement as another example.
The piece concludes: "The best way to reduce smoking deaths isn't more regulation with its unintended consequences. The better policy is to make sure that smokers bear the full risk and cost of their unhealthy habit -- through adjusted insurance premiums -- and by encouraging the use of safer tobacco products. The Kennedy-Waxman bill deserves to be called the Marlboro Preservation Act."
The Rest of the Story
This is truly a brilliant editorial. Add this to Dr. Elizabeth Whelan's outstanding op-ed in the Washington Times and the FDA chief's rejection of the idea of regulating tobacco products. All three not only find substantial flaws in the proposed regulatory approach, but they also conclude that the legislation may do more harm than good. In other words, rather than saving countless lives as the Campaign for Tobacco-Free Kids has claimed, the legislation could well result in increased deaths.
Clearly, it is time that the health groups supporting the bill get the message that they are making a huge mistake. It is hard to believe that this legislation - which is being soundly picked apart from all sides - still has the support of most major anti-smoking and public health groups.
Why? How could this have happened?
The answer is, I believe, quite simple. The Campaign for Tobacco-Free Kids succeeded in its massive deception of the health groups. It appears that the Campaign was not forthright in making it clear to the other health groups that the bill contained numerous provisions that were inserted strictly to protect the financial interests of the nation's largest cigarette company. It appears that the Campaign failed to explain that the bill resulted essentially from a negotiation between itself and Philip Morris. At one point, the Campaign was not even being forthright that the legislation was supported by Philip Morris.
The result of all of this, I believe, is that many of the health groups really didn't have much of an idea of the specifics of the bill and an understanding of what it would actually do, and not do. The information put out by the Campaign has been full of rhetoric and grandiose promises, but devoid of any specific information about the details of the regulatory scheme or any clear scientific or policy justification for the proposal. The propaganda campaign also failed to present a balanced picture of the legislation and the scientific, policy, and political issues involved, resulting in what I suspect is the deception of many health groups into supporting a piece of legislation that they might well not have supported had they been informed about all of these details, rather than merely fed with propaganda. And I suspect that a number of these groups are going to regret having stood on the side of Philip Morris now.
Tuesday, March 13, 2007
College of The Albemarle Ban on Tobacco Use Anywhere on Campus Goes Into Effect Tomorrow
According to an article in the Virginian-Pilot, the College of The Albemarle - a community college in North Carolina
From the article: "Already unwelcome at a growing number of restaurants and high school campuses in North Carolina, smokers are now being banished from College of The Albemarle. Starting Wednesday, COA will become the first community college inNorth Carolina
The Rest of the Story
This is going too far.
Those who are familiar with this blog know that I am all for protecting the public from secondhand smoke exposure in places where they cannot easily avoid that exposure. But a complete ban on smoking on an entire campus, including in parked cars in parking lots, is going too far.
Obviously, this policy is not about protecting the public from secondhand smoke exposure. It is about trying to protect smokers from themselves. In other words, it is a classic case of health paternalism. Or to put it another way - the lifestyle police.
Years ago, when I was lobbying for smoke-free workplace ordinances in communities around the country, I would often be confronted by smokers' rights advocates who would argue that the anti-smoking movement is the lifestyle police who are trying to tell people what they should and should not be doing. At the time, I would respond by saying "No - we're not. We're just trying to prevent you from smoking in locations where other people can't avoid that exposure."
Well - apparently, I was wrong. This has clearly become about more than just protecting the nonsmoker from secondhand smoke exposure. We are now trying to tell people what they should and should not be doing, and what they can and cannot do in terms of their own health risks.
While I think it is entirely appropriate for the college to be concerned about the health of its community and to promote healthy behavior among its faculty, staff, and students, I do not believe that it is appropriate for the college to dictate the health behavior of its community members on campus when it does not directly affect others.
If the college really wants to promote a healthy lifestyle on campus, then why doesn't it also ban the ingestion of fatty foods or high-calorie soft drinks on campus? And should it not also require students to wash their hands after using the bathroom? And how about requiring the HPV vaccine for all female students? Or requiring students to lose enough weight to bring their body mass index down below 25 before they can show up on campus? And how about requiring students to take multivitamins and antioxidants, which have been proven to improve health status signficantly? How about banning the ingestion of trans-fats on campus? Requiring all persons' blood pressures on campus to be below 140/90? Higher than that and they are at increased risk of cardiovascular disease.
There are a lot of health behaviors that a college campus can dictate. For all but smoking, the college chooses to engage in appropriate health education and health promotion interventions. Smoking, however, is singled out as the one behavior that must be dictated. Why?
The upshot of this new policy is that the college is going to alienate many of the smokers in the community. And it is going to have the result of keeping out many high school students or young adults who smoke, but will choose not to attend the college because of its attempt at lifestyle control.
This is the kind of thing that is going to give public health in general, and tobacco control specifically, a bad name. We already have enough people calling us the lifestyle police and accusing us of not respecting individual freedom and autonomy. Do we have to give them more ammunition? More importantly, do we need to prove them right?
From the article: "Already unwelcome at a growing number of restaurants and high school campuses in North Carolina, smokers are now being banished from College of The Albemarle. Starting Wednesday, COA will become the first community college in
The Rest of the Story
This is going too far.
Those who are familiar with this blog know that I am all for protecting the public from secondhand smoke exposure in places where they cannot easily avoid that exposure. But a complete ban on smoking on an entire campus, including in parked cars in parking lots, is going too far.
Obviously, this policy is not about protecting the public from secondhand smoke exposure. It is about trying to protect smokers from themselves. In other words, it is a classic case of health paternalism. Or to put it another way - the lifestyle police.
Years ago, when I was lobbying for smoke-free workplace ordinances in communities around the country, I would often be confronted by smokers' rights advocates who would argue that the anti-smoking movement is the lifestyle police who are trying to tell people what they should and should not be doing. At the time, I would respond by saying "No - we're not. We're just trying to prevent you from smoking in locations where other people can't avoid that exposure."
Well - apparently, I was wrong. This has clearly become about more than just protecting the nonsmoker from secondhand smoke exposure. We are now trying to tell people what they should and should not be doing, and what they can and cannot do in terms of their own health risks.
While I think it is entirely appropriate for the college to be concerned about the health of its community and to promote healthy behavior among its faculty, staff, and students, I do not believe that it is appropriate for the college to dictate the health behavior of its community members on campus when it does not directly affect others.
If the college really wants to promote a healthy lifestyle on campus, then why doesn't it also ban the ingestion of fatty foods or high-calorie soft drinks on campus? And should it not also require students to wash their hands after using the bathroom? And how about requiring the HPV vaccine for all female students? Or requiring students to lose enough weight to bring their body mass index down below 25 before they can show up on campus? And how about requiring students to take multivitamins and antioxidants, which have been proven to improve health status signficantly? How about banning the ingestion of trans-fats on campus? Requiring all persons' blood pressures on campus to be below 140/90? Higher than that and they are at increased risk of cardiovascular disease.
There are a lot of health behaviors that a college campus can dictate. For all but smoking, the college chooses to engage in appropriate health education and health promotion interventions. Smoking, however, is singled out as the one behavior that must be dictated. Why?
The upshot of this new policy is that the college is going to alienate many of the smokers in the community. And it is going to have the result of keeping out many high school students or young adults who smoke, but will choose not to attend the college because of its attempt at lifestyle control.
This is the kind of thing that is going to give public health in general, and tobacco control specifically, a bad name. We already have enough people calling us the lifestyle police and accusing us of not respecting individual freedom and autonomy. Do we have to give them more ammunition? More importantly, do we need to prove them right?
Monday, March 12, 2007
Trading Small Risk for Severe Harm: Why Criminalizing Parental Smoking in Cars is a Terrible Idea
The Illinois legislature is currently considering a bill that would make smoking in a car with a child a criminal offense, punishable by a fine of up to $1,500 and up to one month in jail. A number of anti-smoking groups and advocates are supporting this and similar proposals which would ban smoking in cars with children present. Many of these bills do not make smoking in cars a criminal offense; however, bills being considered in Illinois, New Jersey, and New York do: repeat violations of the law could result in a jail sentence.
I have already expressed my opposition to these measures based on my belief that they represent an unwarranted intrusion into individual privacy and parental autonomy. I would oppose these measures whether they make smoking in cars a civil or a criminal offense. In this post, however, I specifically address those bills which would make smoking in cars with children a criminal offense and explain why I think these measures in particular are misguided and dangerous.
The Rest of the Story
Essentially, these laws would trade off small health risks (a small probability of relatively minor harm) for definite and substantial harm to children (a 100% probability of severe harm).
A child exposed to secondhand smoke for a short period of time in a car is at a somewhat increased risk of ear infections and upper respiratory infections. But that's it. We're not talking about the risk of death or severe injury or illness. And we're not talking about an extremely high probability of illness. Most children who ride in a car in which a parent is smoking for a short period of time will not develop an ear infection or an upper respiratory tract infection. What these laws are doing, then, is protecting children from a relative small risk of relatively minor harm.
In contrast, putting a child's parent behind bars for a month causes severe and definite harm to a child. There is nothing more harmful to a child than forced separation from a parent. We're not talking about an increased risk of an adverse consequence. We're talking about definite harm. And we're not talking about minor harm. We're talking about one of the most severe forms of harm imaginable.
How can we possibly trade a small risk of relatively minor health consequences for definite, severe harm to a child?
The answer is that we can't, or at least we shouldn't. That's why I view the proposals (such as those in Illinois and New York) which criminalize smoking in cars with a child present in order to protect those children as misguided and dangerous.
The rest of the story is that in their zeal to protect children from secondhand smoke exposure (which is admirable), a number of anti-smoking groups are going to cause definite and substantial harm to children (which is not admirable). In what possible way does forcibly removing a parent from a child protect that child? How can it possibly be in a child's best interest to remove a parent from them and lock him or her up in jail merely to prevent the slight possibility that the child might develop an ear or upper respiratory infection?
In cases of child abuse, I think that criminalization of the parent and removal of the child from the parent is a reasonable potential option because it is possible that the harm from the child abuse outweighs the harm from the removal of the child from the parent. If a child is being repeatedly beaten or sexually abused, that degree of harm unfortunately is so severe that removing the child from the parent may actually be in the best overall interest of the child.
But how is removing a parent from a child, even for a few weeks or a month, in order to reduce the risk of an ear or bronchial infection, in the best interests of the child?
I'm afraid that in our desire to reduce children's exposure to secondhand smoke, which is a laudable goal, we have lost sight of the broader and more fundamental goal: protecting children from harm. And in our desire to reduce health risks, we are now supporting proposals that are destined to cause harm for many children.
I think that we in tobacco control have become very narrow-minded in our view of the world. And that narrow perspective we now bring to public health is unfortunately going to start causing harm. Someone needs to speak out to try to open up our thinking and our perspective, and to remind us why we are doing this in the first place. I'm glad that's a role that The Rest of the Story can play.
While it is my hope that as many of the car smoking ban proposals fail as possible, I think it is particularly critical that the measures which making smoking in cars a criminal offense go down to defeat. Enacting such measures is not in the best interests of our children.
I have already expressed my opposition to these measures based on my belief that they represent an unwarranted intrusion into individual privacy and parental autonomy. I would oppose these measures whether they make smoking in cars a civil or a criminal offense. In this post, however, I specifically address those bills which would make smoking in cars with children a criminal offense and explain why I think these measures in particular are misguided and dangerous.
The Rest of the Story
Essentially, these laws would trade off small health risks (a small probability of relatively minor harm) for definite and substantial harm to children (a 100% probability of severe harm).
A child exposed to secondhand smoke for a short period of time in a car is at a somewhat increased risk of ear infections and upper respiratory infections. But that's it. We're not talking about the risk of death or severe injury or illness. And we're not talking about an extremely high probability of illness. Most children who ride in a car in which a parent is smoking for a short period of time will not develop an ear infection or an upper respiratory tract infection. What these laws are doing, then, is protecting children from a relative small risk of relatively minor harm.
In contrast, putting a child's parent behind bars for a month causes severe and definite harm to a child. There is nothing more harmful to a child than forced separation from a parent. We're not talking about an increased risk of an adverse consequence. We're talking about definite harm. And we're not talking about minor harm. We're talking about one of the most severe forms of harm imaginable.
How can we possibly trade a small risk of relatively minor health consequences for definite, severe harm to a child?
The answer is that we can't, or at least we shouldn't. That's why I view the proposals (such as those in Illinois and New York) which criminalize smoking in cars with a child present in order to protect those children as misguided and dangerous.
The rest of the story is that in their zeal to protect children from secondhand smoke exposure (which is admirable), a number of anti-smoking groups are going to cause definite and substantial harm to children (which is not admirable). In what possible way does forcibly removing a parent from a child protect that child? How can it possibly be in a child's best interest to remove a parent from them and lock him or her up in jail merely to prevent the slight possibility that the child might develop an ear or upper respiratory infection?
In cases of child abuse, I think that criminalization of the parent and removal of the child from the parent is a reasonable potential option because it is possible that the harm from the child abuse outweighs the harm from the removal of the child from the parent. If a child is being repeatedly beaten or sexually abused, that degree of harm unfortunately is so severe that removing the child from the parent may actually be in the best overall interest of the child.
But how is removing a parent from a child, even for a few weeks or a month, in order to reduce the risk of an ear or bronchial infection, in the best interests of the child?
I'm afraid that in our desire to reduce children's exposure to secondhand smoke, which is a laudable goal, we have lost sight of the broader and more fundamental goal: protecting children from harm. And in our desire to reduce health risks, we are now supporting proposals that are destined to cause harm for many children.
I think that we in tobacco control have become very narrow-minded in our view of the world. And that narrow perspective we now bring to public health is unfortunately going to start causing harm. Someone needs to speak out to try to open up our thinking and our perspective, and to remind us why we are doing this in the first place. I'm glad that's a role that The Rest of the Story can play.
While it is my hope that as many of the car smoking ban proposals fail as possible, I think it is particularly critical that the measures which making smoking in cars a criminal offense go down to defeat. Enacting such measures is not in the best interests of our children.
Friday, March 09, 2007
Illinois Smokers Could Face a Month in Prison for Smoking in a Car With Children
Under the terms a bill sponsored by Illinois state senator Mike Boland, people who smoke in a car with children under 9 years old present would be guilty of a state crime - a misdemenaor - and would be subject to up to a $1,500 fine and a month in prison (see Chicago Tribune article).
According to the article: "Illinois could join the short list of states that bar people from smoking in cars when children are present, under legislation introduced by Rep. Mike Boland. Boland wants to make it a misdemeanor to smoke in a car if any of the passengers are 8 or younger. Violators could be slapped with a $1,500 fine and a month in jail. The Moline Democrat said he was inspired when he walked past a car filled with a cloud of smoke from the driver's cigarette. 'I saw some little heads in their little car seats and thought 'Gee, that's really awful,'' Boland said."
The Rest of the Story
I agree. That is really awful. But is it worth sending a parent to jail for a month to teach them a lesson about what the state thinks they should be doing to protect the health of their kids? In what possible way does it help the child to have their parent removed from them for a month? I can hardly think of a more damaging thing for a child - and that includes exposure to secondhand smoke.
Do we really want to make criminals out of parents who, for one thing, might not know that secondhand smoke is hazardous for their children? Or even if they do know that, should it make a parent a criminal if he or she makes a reasoned decision that the risk of ear or upper respiratory infection from secondhand smoke is not enough to outweigh their own desire to smoke, or the need for them to avoid withdrawal symptoms from nicotine dependence? Or if they judge that with the windows open and moving fast on a highway, the smoke will not accumulate substantially in the car?
Moreover, if parents who smoke in a car are criminals, then aren't parents who serve their children alcohol also criminals? Or parents who take their kids to fast food restaurants five nights a week? Or parents who let their kids eat fluff? Or parents who allow their kids to go skiing without wearing a helmet? Or parents who don't put up a secure safety gate at the top of a staircase in their home? Or parents who don't check the batteries of their smoke detectors every six months?
Perhaps we should just open up a special wing of our prisons for all the parents who expose their children to health risks.
I can see it now:
What are you in for?
I let my kid go rollerblading and he wasn't wearing a helmet and wrist guards. He had a concussion and had to be hospitalized overnight. Plus, he broke his wrist.
How about you?
I didn't realize my kid needed sunscreen even though it's only May. He was out for a few hours and got a pretty bad sunburn. Hey - looks like they're putting that guy in the slammer. Hey, what are you in for?
I smoked in a car with my seven year-old.
Were the windows open?
Yes.
Were you going fast?
Yes.
Well what happened to your kid? Is he sick? Was he hospitalized?
No, he's absolutely fine. I'm just here because the police said there was a chance he might get an ear infection from the smoke in the car.
According to the article: "Illinois could join the short list of states that bar people from smoking in cars when children are present, under legislation introduced by Rep. Mike Boland. Boland wants to make it a misdemeanor to smoke in a car if any of the passengers are 8 or younger. Violators could be slapped with a $1,500 fine and a month in jail. The Moline Democrat said he was inspired when he walked past a car filled with a cloud of smoke from the driver's cigarette. 'I saw some little heads in their little car seats and thought 'Gee, that's really awful,'' Boland said."
The Rest of the Story
I agree. That is really awful. But is it worth sending a parent to jail for a month to teach them a lesson about what the state thinks they should be doing to protect the health of their kids? In what possible way does it help the child to have their parent removed from them for a month? I can hardly think of a more damaging thing for a child - and that includes exposure to secondhand smoke.
Do we really want to make criminals out of parents who, for one thing, might not know that secondhand smoke is hazardous for their children? Or even if they do know that, should it make a parent a criminal if he or she makes a reasoned decision that the risk of ear or upper respiratory infection from secondhand smoke is not enough to outweigh their own desire to smoke, or the need for them to avoid withdrawal symptoms from nicotine dependence? Or if they judge that with the windows open and moving fast on a highway, the smoke will not accumulate substantially in the car?
Moreover, if parents who smoke in a car are criminals, then aren't parents who serve their children alcohol also criminals? Or parents who take their kids to fast food restaurants five nights a week? Or parents who let their kids eat fluff? Or parents who allow their kids to go skiing without wearing a helmet? Or parents who don't put up a secure safety gate at the top of a staircase in their home? Or parents who don't check the batteries of their smoke detectors every six months?
Perhaps we should just open up a special wing of our prisons for all the parents who expose their children to health risks.
I can see it now:
What are you in for?
I let my kid go rollerblading and he wasn't wearing a helmet and wrist guards. He had a concussion and had to be hospitalized overnight. Plus, he broke his wrist.
How about you?
I didn't realize my kid needed sunscreen even though it's only May. He was out for a few hours and got a pretty bad sunburn. Hey - looks like they're putting that guy in the slammer. Hey, what are you in for?
I smoked in a car with my seven year-old.
Were the windows open?
Yes.
Were you going fast?
Yes.
Well what happened to your kid? Is he sick? Was he hospitalized?
No, he's absolutely fine. I'm just here because the police said there was a chance he might get an ear infection from the smoke in the car.
Wednesday, March 07, 2007
Study Finds No Benefit to Use of CT Scans to Screen Current and Former Smokers for Lung Cancer
A study published in this week's issue of the Journal of the American Medical Association (JAMA) concludes that CT scan screening of asymptomatic current and ex-smokers in an effort to detect lung cancer earlier has no benefit in terms of reducing mortality. In fact, using such an approach on a population basis could produce more harm than benefit (see: Bach PB, Jett JR, Pastorino U, Tockman MS, Swensen SJ, Begg CB. Computed tomography screening and lung cancer outcomes. JAMA 2007; 297:953-961).
The conclusions were based on a longitudinal study of over 3,000 current and ex-smokers screened for lung cancer using chest CT scans at 3 different academic medical centers. The average follow-up time was 4 years. Subjects underwent baseline and annual low-dose CT scans. There was no difference in lung cancer mortality: the number of lung cancer deaths was nearly the same as predicted (relative risk = 1.0).
The authors conclude: "Screening for lung cancer with low-dose CT may increase the rate of lung cancer diagnosis and treatment, but may not meaningfully reduce the risk of advanced lung cancer or death from lung cancer. Until more conclusive data are available, asymptomatic individuals should not be screened outside of clinical research studies that have a reasonable likelihood of further clarifying the potential benefits and risks."
Not only did the authors fail to find any benefit of CT screening for lung cancer, but they also identified substantial potential harm - the invasive diagnostic procedures required by the finding of what turn out to be benign lung nodules carry with them their own morbidity and mortality risks. They conclude that: "If the majority of excess early cancers found through screening are unlikely to progress rapidly to a point where they cause clinically significant disease or death, then the thoracic surgeries performed to remove them may be insufficiently beneficial to justify the resulting morbidities. Despite some studies that have demonstrated excellent outcomes when lung cancer resections are performed in high-volume hospitals by thoracic surgeons, excellent outcomes are not uniform. Rather, the postoperative mortality rate following resection of lung cancer in the United States averages 5%, and the frequency of serious complications ranges from 20% to 44%. ... biopsies and the other diagnostic procedures that are performed in response to findings on a screening CT constitute another potential downstream harm that could result from widespread CT screening."
The Rest of the Story
While we need to await the results of a large clinical trial of low-dose CT screening for lung cancer before drawing any definitive conclusions, what is clear is that at the present time, there insufficient evidence that the use of CT screening for lung cancer produces any benefit in terms of reducing mortality.
On the other hand, it is clear that the use of CT screening on a large population of smokers and ex-smokers would produce substantial harms. There is a significant risk of morbidity and mortality from the invasive diagnostic procedures required to investigate the large number of lung nodules that will inevitably be detected on CT scan, most of which will end up being benign.
While it is not entirely clear why no mortality benefit was observed even though the screening procedure did result in a large increase in the number of lung cancers detected, the authors postulate that what is happening is that the CT scans are picking up lung cancer nodules that are so small that they would never have progressed to the point that they caused death anyway. This is known as "overdiagnosis" bias and it is a common limitation of this type of screening approach.
Despite the lack of sufficient evidence that there is any benefit to the use of CT screening for lung cancer among current and ex-smokers, the Lung Cancer Alliance - a lung cancer advocacy group - issued a press release in which it stood by its position that people at risk of lung cancer (e.g., smokers and former smokers) should be encouraged to undergo CT scan screening for lung cancer:
"Today, Lung Cancer Alliance President, Laurie Fenton, responded to the most recent criticism of CT screening, calling it 'another delaying tactic to deny people at high risk for lung cancer the chance to have it detected at an early, treatable stage.' ... An article published in the March 7 issue of the Journal of the American Medical Association concludes that high risk individuals should not be screened for lung cancer until more studies have been conducted, as the authors claim CT scans may cause more harm than good. 'This is not productive,' declared Fenton. “We have heard these same statistical arguments used for years... ."
While I admire the Lung Cancer Alliance and the important work they are doing on behalf of lung cancer victims and their families, as well as the work they are doing to try to prevent and more effectively treat lung cancer, I think that advocacy needs to remain science-based. The science simply does not support a recommendation that lung cancer screening be conducted on a population basis at this point in time.
While it is possible that results from the large clinical trial that is now underway could produce very different results, we simply don't have that information yet. In the absence of evidence that screening actually will save lives, I do not believe that the risks of screening outweigh the benefits.
I do not believe this is a delaying tactic. I believe it is wise and responsible public health practice based on the best available science at the time. I also think it is very productive, because it could save people a tremendous amount of unnecessary morbidity and even mortality.
The rest of the story is that while our emotions tell us that we would love to have a way to prevent the devastating effects of lung cancer, the science tells us that CT screening is not yet documented to represent that way. There is no clear mortality benefit that has been demonstrated, yet the harm done by causing unnecesary anxiety among smokers and ex-smokers, and by causing unnecessary morbidity from invasive diagnostic tests, could be substantial.
The conclusions were based on a longitudinal study of over 3,000 current and ex-smokers screened for lung cancer using chest CT scans at 3 different academic medical centers. The average follow-up time was 4 years. Subjects underwent baseline and annual low-dose CT scans. There was no difference in lung cancer mortality: the number of lung cancer deaths was nearly the same as predicted (relative risk = 1.0).
The authors conclude: "Screening for lung cancer with low-dose CT may increase the rate of lung cancer diagnosis and treatment, but may not meaningfully reduce the risk of advanced lung cancer or death from lung cancer. Until more conclusive data are available, asymptomatic individuals should not be screened outside of clinical research studies that have a reasonable likelihood of further clarifying the potential benefits and risks."
Not only did the authors fail to find any benefit of CT screening for lung cancer, but they also identified substantial potential harm - the invasive diagnostic procedures required by the finding of what turn out to be benign lung nodules carry with them their own morbidity and mortality risks. They conclude that: "If the majority of excess early cancers found through screening are unlikely to progress rapidly to a point where they cause clinically significant disease or death, then the thoracic surgeries performed to remove them may be insufficiently beneficial to justify the resulting morbidities. Despite some studies that have demonstrated excellent outcomes when lung cancer resections are performed in high-volume hospitals by thoracic surgeons, excellent outcomes are not uniform. Rather, the postoperative mortality rate following resection of lung cancer in the United States averages 5%, and the frequency of serious complications ranges from 20% to 44%. ... biopsies and the other diagnostic procedures that are performed in response to findings on a screening CT constitute another potential downstream harm that could result from widespread CT screening."
The Rest of the Story
While we need to await the results of a large clinical trial of low-dose CT screening for lung cancer before drawing any definitive conclusions, what is clear is that at the present time, there insufficient evidence that the use of CT screening for lung cancer produces any benefit in terms of reducing mortality.
On the other hand, it is clear that the use of CT screening on a large population of smokers and ex-smokers would produce substantial harms. There is a significant risk of morbidity and mortality from the invasive diagnostic procedures required to investigate the large number of lung nodules that will inevitably be detected on CT scan, most of which will end up being benign.
While it is not entirely clear why no mortality benefit was observed even though the screening procedure did result in a large increase in the number of lung cancers detected, the authors postulate that what is happening is that the CT scans are picking up lung cancer nodules that are so small that they would never have progressed to the point that they caused death anyway. This is known as "overdiagnosis" bias and it is a common limitation of this type of screening approach.
Despite the lack of sufficient evidence that there is any benefit to the use of CT screening for lung cancer among current and ex-smokers, the Lung Cancer Alliance - a lung cancer advocacy group - issued a press release in which it stood by its position that people at risk of lung cancer (e.g., smokers and former smokers) should be encouraged to undergo CT scan screening for lung cancer:
"Today, Lung Cancer Alliance President, Laurie Fenton, responded to the most recent criticism of CT screening, calling it 'another delaying tactic to deny people at high risk for lung cancer the chance to have it detected at an early, treatable stage.' ... An article published in the March 7 issue of the Journal of the American Medical Association concludes that high risk individuals should not be screened for lung cancer until more studies have been conducted, as the authors claim CT scans may cause more harm than good. 'This is not productive,' declared Fenton. “We have heard these same statistical arguments used for years... ."
While I admire the Lung Cancer Alliance and the important work they are doing on behalf of lung cancer victims and their families, as well as the work they are doing to try to prevent and more effectively treat lung cancer, I think that advocacy needs to remain science-based. The science simply does not support a recommendation that lung cancer screening be conducted on a population basis at this point in time.
While it is possible that results from the large clinical trial that is now underway could produce very different results, we simply don't have that information yet. In the absence of evidence that screening actually will save lives, I do not believe that the risks of screening outweigh the benefits.
I do not believe this is a delaying tactic. I believe it is wise and responsible public health practice based on the best available science at the time. I also think it is very productive, because it could save people a tremendous amount of unnecessary morbidity and even mortality.
The rest of the story is that while our emotions tell us that we would love to have a way to prevent the devastating effects of lung cancer, the science tells us that CT screening is not yet documented to represent that way. There is no clear mortality benefit that has been demonstrated, yet the harm done by causing unnecesary anxiety among smokers and ex-smokers, and by causing unnecessary morbidity from invasive diagnostic tests, could be substantial.
Washington Times Op-Ed Blasts Proposed FDA Tobacco Legislation
In an op-ed piece appearing today in the Washington Times, Dr. Elizabeth M. Whelan - Executive Director of the American Council on Science and Health - blasts the proposed FDA tobacco legislation, arguing that it would actually harm and not protect the public's health.
Dr. Whelan writes that: "The bill's proponents, including Sen. Ted Kennedy, Massachusetts Democrat, argue that FDA authority over tobacco will lead to a safer cigarette, stronger warning labels and a reduction in cigarette-related deaths. At first blush, this sounds like great news. But tragically, the proposed legislation will have exactly the opposite effect -- and will likely increase smoking-related deaths."
Dr. Whelan provides four arguments to back up her assertion that the legislation would not improve the public's health, and would in fact could cause great harm.
First, she argues that the regulatory framework of the bill - asking FDA to reduce levels of specific constituents in tobacco smoke - makes no sense since there are thousands of toxins in the smoke and it is not any one or a small number of these chemicals that are responsible for the harmful effects of smoking.
Second, she notes that the bill would ask the FDA to reduce, but not eliminate nicotine in cigarettes. This would result in increased cigarette consumption (and increased health effects) due to the phenomenon of compensation (smokers would smoke more to inhale the same amount of nicotine as they do now).
Third, the bill does not allow for any suggestion that one type of tobacco product may be less harmful than another. This makes it difficult for the risks of the products to be communicated accurately.
Fourth, the bill would create an FDA stamp of approval for tobacco products, misleading people about the true hazards of cigarettes and providing virtual legal immunity for the tobacco companies.
The Rest of the Story
There is little I can add to Dr. Whelan's well-argued, cogent, and compelling commentary on this legislation. I can only hope that policy makers will take heed to her comments.
But more importantly, I hope that the strength of her argument will cause the major health groups championing this proposal - the Campaign for Tobacco-Free Kids, American Cancer Society, American Lung Association, and American Heart Association - to realize the error of their ways and to immediately withdraw their support of the bill. That would be a true service to the public's health.
Dr. Whelan writes that: "The bill's proponents, including Sen. Ted Kennedy, Massachusetts Democrat, argue that FDA authority over tobacco will lead to a safer cigarette, stronger warning labels and a reduction in cigarette-related deaths. At first blush, this sounds like great news. But tragically, the proposed legislation will have exactly the opposite effect -- and will likely increase smoking-related deaths."
Dr. Whelan provides four arguments to back up her assertion that the legislation would not improve the public's health, and would in fact could cause great harm.
First, she argues that the regulatory framework of the bill - asking FDA to reduce levels of specific constituents in tobacco smoke - makes no sense since there are thousands of toxins in the smoke and it is not any one or a small number of these chemicals that are responsible for the harmful effects of smoking.
Second, she notes that the bill would ask the FDA to reduce, but not eliminate nicotine in cigarettes. This would result in increased cigarette consumption (and increased health effects) due to the phenomenon of compensation (smokers would smoke more to inhale the same amount of nicotine as they do now).
Third, the bill does not allow for any suggestion that one type of tobacco product may be less harmful than another. This makes it difficult for the risks of the products to be communicated accurately.
Fourth, the bill would create an FDA stamp of approval for tobacco products, misleading people about the true hazards of cigarettes and providing virtual legal immunity for the tobacco companies.
The Rest of the Story
There is little I can add to Dr. Whelan's well-argued, cogent, and compelling commentary on this legislation. I can only hope that policy makers will take heed to her comments.
But more importantly, I hope that the strength of her argument will cause the major health groups championing this proposal - the Campaign for Tobacco-Free Kids, American Cancer Society, American Lung Association, and American Heart Association - to realize the error of their ways and to immediately withdraw their support of the bill. That would be a true service to the public's health.
Tuesday, March 06, 2007
FDA Head Rejects Idea of Regulating Tobacco; Says Regulation by FDA is Inappropriate and Would Make Problem Worse
In an interview with the Associated Press published today by BusinessWeek.com, Dr. Andrew von Eschenbach - head of the Food and Drug Administration (FDA) - rejected the idea of the FDA regulating tobacco products, saying that the approach proposed by Philip Morris and major anti-smoking groups is inappropriate, would increase cigarette consumption, and would make the problem worse, not better.
According to the article: "Government regulation of tobacco could backfire by inadvertently forcing smokers to light up more and inhale more deeply, the head of the Food and Drug Administration said Tuesday."
Dr. von Eschenbach was quoted as stating: "We could find ourselves in the conundrum of having made a decision about nicotine only to have made the public health radically worse. And that is not the position FDA is in; we approve products that enhance health, not destroy it. ... What I don't want to see happen is that we are in a position where we are determining that a cigarette is safe."
The Rest of the Story
This is a crushing blow to the position that jurisdiction over the safety of tobacco products should be placed in the hands of the FDA and that such regulation would substantially improve the public's health.
The FDA wants no part of it, feels that it is an absurd approach, and is concerned that it would harm, rather than protect, the public's health.
Dr. von Eschenbach makes what probably is the strongest argument yet against the proposed FDA tobacco legislation: the Food and Drug Administration is about approving products that treat medical conditions, not cause them.
Ultimately, the FDA is an agency which approves products for use by consumers. How can we ask the FDA to approve a product that we know is going to kill thousands of people?
Dr. von Eschenbach also makes the point I have been trying to make repeatedly over the past few weeks that reducing nicotine levels in cigarettes will cause smokers to inhale more deeply and smoke more and this could make the public's health "radically worse."
It becomes far less tenable to promote this policy proposal when the Agency you are asking to assume jurisdiction over the product doesn't want any part of it. Maybe the Campaign for Tobacco-Free Kids, American Cancer Society, AMA, and other anti-smoking groups supporting the idea should have spoken with Dr. von Eschenbach first, before trying to ram this misguided idea down the FDA's throat.
According to the article: "Government regulation of tobacco could backfire by inadvertently forcing smokers to light up more and inhale more deeply, the head of the Food and Drug Administration said Tuesday."
Dr. von Eschenbach was quoted as stating: "We could find ourselves in the conundrum of having made a decision about nicotine only to have made the public health radically worse. And that is not the position FDA is in; we approve products that enhance health, not destroy it. ... What I don't want to see happen is that we are in a position where we are determining that a cigarette is safe."
The Rest of the Story
This is a crushing blow to the position that jurisdiction over the safety of tobacco products should be placed in the hands of the FDA and that such regulation would substantially improve the public's health.
The FDA wants no part of it, feels that it is an absurd approach, and is concerned that it would harm, rather than protect, the public's health.
Dr. von Eschenbach makes what probably is the strongest argument yet against the proposed FDA tobacco legislation: the Food and Drug Administration is about approving products that treat medical conditions, not cause them.
Ultimately, the FDA is an agency which approves products for use by consumers. How can we ask the FDA to approve a product that we know is going to kill thousands of people?
Dr. von Eschenbach also makes the point I have been trying to make repeatedly over the past few weeks that reducing nicotine levels in cigarettes will cause smokers to inhale more deeply and smoke more and this could make the public's health "radically worse."
It becomes far less tenable to promote this policy proposal when the Agency you are asking to assume jurisdiction over the product doesn't want any part of it. Maybe the Campaign for Tobacco-Free Kids, American Cancer Society, AMA, and other anti-smoking groups supporting the idea should have spoken with Dr. von Eschenbach first, before trying to ram this misguided idea down the FDA's throat.
Monday, March 05, 2007
FDA Legislation Ensures No Meaningful Regulation Could Take Place; Major Decisions Reserved to Congress; Politics, Not Science Would Dictate Policy
Although I've argued that the regulatory scheme that would be established by the proposed FDA tobacco legislation is absurd and that it would do nothing to protect the public's health and a lot to harm public health, the legislation contains an additional protection to ensure that any meaningful regulation of tobacco products that might actually accomplish something useful could easily be blocked by the tobacco companies.
It's something I call the Philip Morris escape clause, and it essentially establishes procedures so that Congress, rather than the FDA, would make the final decisions regarding any major tobacco regulations. This would ensure that the major decisions are based on politics, rather than science and public health policy concerns. And this is precisely what Philip Morris wants, because it enables the tobacco companies to use their influence with Congress to block any meaningful FDA tobacco rules with a simple majority vote of both houses of Congress.
Moreover, the legislative process that must be followed for Congress to overrule any major FDA rule is a streamlined one: all that is required is a joint resolution of Congress. The rules have been changed so that it becomes much harder to block such a resolution. Many of the usual parliamentary procedures that can be used to block legislation cannot be employed to block these joint resolutions to overturn FDA tobacco regulations.
And here's the kicker: if Congress does overturn a particular rule, it is permanent. The FDA is forever prohibited from re-issuing that rule or anything similar until such time as Congress decides to allow the Agency to do so.
In other words, the legislation gives Congress undue control over the regulatory process, ensuring that the tobacco companies can rely upon their influence on politicians to block any regulation that would be harmful to their profits.
Perhaps the most important implication of this escape clause is that it would ensure that the FDA never is able to reduce nicotine levels in cigarettes to extremely low levels. Any attempt by FDA to reduce the nicotine levels so low that they threatened to reduce cigarette consumption would be met, without a doubt, by a unified lobbying effort by the tobacco companies to get Congress to disapprove those regulations. And again, a streamlined process with only a majority vote and without the usual parliamentary blocking procedures is prescribed by the legislation.
The bill makes it as easy as possible for the tobacco companies to block any meaningful regulation of their products. Politics, and tobacco industry profits, not science, is left as the ultimate arbiter of the public's health.
There is no way, for example, that Congress would allow the FDA to reduce nicotine levels so far that they substantially reduce cigarette consumption and threaten tobacco industry profits, as well as government (federal and state) revenues. Especially with the dependence of so many critical government programs on cigarette revenues (thanks to the Master Settlement Agreement), Congress would never allow any FDA regulation that would threaten cigarette consumption substantially.
The Rest of the Story
The FDA tobacco legislation, which is supported by Philip Morris and the Campaign for Tobacco-Free Kids and many other major anti-smoking groups, contains an escape clause that would allow Philip Morris or any other tobacco company to appeal to Congress to overturn any major regulation that the company does not like. The legislation explicitly gives Congress the ability to review and, by majority vote, to overturn, within 60 days, any major tobacco rules promulgated by FDA, resulting in such rule having no force or effect.
Such a Congressional decision is final, and permanently enjoins the FDA from re-issuing such a rule: even if political conditions change and Congress might be more favorable towards such a regulation at some future time.
Given the lobbying power of Big Tobacco in Congress, this essentially gives the companies the ability to block any substantial tobacco rules that would be expected to have significant financial consequences -- precisely those which might otherwise have public health benefit. The legislation makes it easier for Big Tobacco to obtain a Congressional override of an FDA rule by prescribing rules for the consideration of such override legislation that limit the ability of legislators who oppose such a measure to kill it (i.e., it prescribes rules that take away many of the procedural moves by which legislation can normally be killed).
By keeping all major regulatory decisions within the oversight of Congress, the legislation politicizes what should be primarily scientific and public health issues. This provision in the legislation essentially represents an "escape clause" by which the tobacco companies could escape unfavorable regulation simply by mobilizing enough support within Congress to pass a joint resolution of rule disapproval. And the rules governing the procedure by which such a joint resolution is considered are geared towards making it more difficult than normal to kill such a measure.
The bill achieves this escape for Big Tobacco by making any major FDA rules subject to section 801 of Title 5 of the United States Code (Congressional review of agency rulemaking).
The killer provision in the bill, almost certainly inserted at the insistence of Philip Morris (and for some inexplicable reason agreed to by the Campaign for Tobacco-Free Kids and other health groups), is section 915, entitled "Congressional Review Provisions." It is tucked away in fine print near the end of the bill, so that you really have to read every word of the bill to even know that it is there.
It states, simply: "In accordance with section 801 of title 5, United 8 States Code, Congress shall review, and may disapprove, any rule under this chapter that is subject to section 801."
And unfortunately, section 801 of title 5 of the United States Code states that: "A rule shall not take effect (or continue), if the Congress enacts a joint resolution of disapproval, described under section 802, of the rule."
Even more unfortunately: "A rule that does not take effect (or does not continue) under paragraph (1) may not be reissued in substantially the same form, and a new rule that is substantially the same as such a rule may not be issued, unless the reissued or new rule is specifically authorized by a law enacted after the date of the joint resolution disapproving the original rule."
In other words, the decision of Congress represents a permanent injunction against FDA issuing that rule.
To add insult to injury, section 802 of title 5 prescribes that: "In the Senate, if the committee to which is referred a joint resolution described in subsection (a) has not reported such joint resolution (or an identical joint resolution) at the end of 20 calendar days after the submission or publication date defined under subsection (b)(2), such committee may be discharged from further consideration of such joint resolution upon a petition supported in writing by 30 Members of the Senate, and such joint resolution shall be placed on the calendar."
What this means is that the resolution to disapprove an FDA tobacco rule cannot be killed in committee. It takes only 30 votes to force the resolution out of committee to the full Senate for a vote.
The icing on the cake is that: "it is at any time thereafter in order (even though a previous motion to the same effect has been disagreed to) for a motion to proceed to the consideration of the joint resolution, and all points of order against the joint resolution (and against consideration of the joint resolution) are waived. The motion is not subject to amendment, or to a motion to postpone, or to a motion to proceed to the consideration of other business. A motion to reconsider the vote by which the motion is agreed to or disagreed to shall not be in order. If a motion to proceed to the consideration of the joint resolution is agreed to, the joint resolution shall remain the unfinished business of the Senate until disposed of."
This provision blocks many of the parliamentary procedures that normally can be used to block legislation. It makes it as easy as possible for the tobacco companies to get a joint resolution of disapproval of an FDA tobacco rule enacted by Congress.
What tobacco control and public health advocates and the public need to realize is that the bill could have exempted these regulations from Congressional review. In fact, the bill does exempt from Congressional review the advertising and youth access regulations that the Secretary of Health and Human Services would be forced to promulgate (the 1996 FDA regulations). However, the remainder of the rules that FDA is given the authority to promulgate are not exempted from the Title 5, Section 801 provisions.
Obviously, Philip Morris does not feel threatened by the youth access regulations (which will do nothing) and advertising restrictions (which will do little and may also be overturned by the Supreme Court). However, a more serious threat, such as one which could threaten its profits, is subject to the Congressional review provisions.
Presumably, the simple inclusion in the legislation of a clause stating that ‘‘Section 801 of Title V of the United States Code does not apply to the regulations referred to in the Family Smoking Prevention and Tobacco Control Act" would allow FDA to regulate tobacco products without explicit Congressional review and would eliminate the short-circuited process by which Congress can override FDA rules under the current bill.
That the Campaign for Tobacco-Free Kids has stated that this legislation is "strong" and puts "protection of the public health first" is unfortunate, given their presumable knowledge that this "Philip Morris escape clause" was tucked away into the bill, apparently with the Campaign's approval.
It is inexplicable to me how any anti-smoking or public health group could support the legislation, given the presence of this clause, which clearly provides special protection to the tobacco companies at the expense of the protection of the public's health.
Even more inexplicable is how these same anti-smoking groups could refuse to consider any amendment to the legislation which would eliminate this escape clause. The Campaign for Tobacco-Free Kids and its friends supporting this legislation have repeatedly refused to entertain any changes to the legislation, even amendments that would substantially strengthen the bill and give it some teeth.
In fact, the American Cancer Society - one group that has joined Philip Morris in promoting this legislation - was quoted in the Winston-Salem Journal as stating that it would oppose any changes to the legislation: "Wendy Selig, the vice president of legislative affairs for the American Cancer Society, said her organization 'strongly supports the bill as it is written now,' and would oppose any changes. 'This bill has been vetted broadly within the health community, (and) I think what this bill sets out to do is a huge step forward for public health,' she said."
I find it very unfortunate that a public health group would be unwilling to consider any improvements in a piece of public health legislation. The appearance of this is that the American Cancer Society has agreed to some back-room deal with Philip Morris and doesn't want to strengthen the bill because they are afraid that the deal will fall through.
That is not serving the public's health. That is protecting the financial interests of Philip Morris at the expense of the public's health.
And ultimately, that's what this whole issue comes down to. The escape clause is one of numerous provisions insisted upon by Philip Morris to protect its profits and ensure that regulation of tobacco products, while real, would be limited and that any meaningful regulation could easily be blocked on political and economic grounds. The public health groups who are supporting the legislation and refusing to even consider strengthening it have essentially sold out the public's health for the financial interests of Big Tobacco.
It's something I call the Philip Morris escape clause, and it essentially establishes procedures so that Congress, rather than the FDA, would make the final decisions regarding any major tobacco regulations. This would ensure that the major decisions are based on politics, rather than science and public health policy concerns. And this is precisely what Philip Morris wants, because it enables the tobacco companies to use their influence with Congress to block any meaningful FDA tobacco rules with a simple majority vote of both houses of Congress.
Moreover, the legislative process that must be followed for Congress to overrule any major FDA rule is a streamlined one: all that is required is a joint resolution of Congress. The rules have been changed so that it becomes much harder to block such a resolution. Many of the usual parliamentary procedures that can be used to block legislation cannot be employed to block these joint resolutions to overturn FDA tobacco regulations.
And here's the kicker: if Congress does overturn a particular rule, it is permanent. The FDA is forever prohibited from re-issuing that rule or anything similar until such time as Congress decides to allow the Agency to do so.
In other words, the legislation gives Congress undue control over the regulatory process, ensuring that the tobacco companies can rely upon their influence on politicians to block any regulation that would be harmful to their profits.
Perhaps the most important implication of this escape clause is that it would ensure that the FDA never is able to reduce nicotine levels in cigarettes to extremely low levels. Any attempt by FDA to reduce the nicotine levels so low that they threatened to reduce cigarette consumption would be met, without a doubt, by a unified lobbying effort by the tobacco companies to get Congress to disapprove those regulations. And again, a streamlined process with only a majority vote and without the usual parliamentary blocking procedures is prescribed by the legislation.
The bill makes it as easy as possible for the tobacco companies to block any meaningful regulation of their products. Politics, and tobacco industry profits, not science, is left as the ultimate arbiter of the public's health.
There is no way, for example, that Congress would allow the FDA to reduce nicotine levels so far that they substantially reduce cigarette consumption and threaten tobacco industry profits, as well as government (federal and state) revenues. Especially with the dependence of so many critical government programs on cigarette revenues (thanks to the Master Settlement Agreement), Congress would never allow any FDA regulation that would threaten cigarette consumption substantially.
The Rest of the Story
The FDA tobacco legislation, which is supported by Philip Morris and the Campaign for Tobacco-Free Kids and many other major anti-smoking groups, contains an escape clause that would allow Philip Morris or any other tobacco company to appeal to Congress to overturn any major regulation that the company does not like. The legislation explicitly gives Congress the ability to review and, by majority vote, to overturn, within 60 days, any major tobacco rules promulgated by FDA, resulting in such rule having no force or effect.
Such a Congressional decision is final, and permanently enjoins the FDA from re-issuing such a rule: even if political conditions change and Congress might be more favorable towards such a regulation at some future time.
Given the lobbying power of Big Tobacco in Congress, this essentially gives the companies the ability to block any substantial tobacco rules that would be expected to have significant financial consequences -- precisely those which might otherwise have public health benefit. The legislation makes it easier for Big Tobacco to obtain a Congressional override of an FDA rule by prescribing rules for the consideration of such override legislation that limit the ability of legislators who oppose such a measure to kill it (i.e., it prescribes rules that take away many of the procedural moves by which legislation can normally be killed).
By keeping all major regulatory decisions within the oversight of Congress, the legislation politicizes what should be primarily scientific and public health issues. This provision in the legislation essentially represents an "escape clause" by which the tobacco companies could escape unfavorable regulation simply by mobilizing enough support within Congress to pass a joint resolution of rule disapproval. And the rules governing the procedure by which such a joint resolution is considered are geared towards making it more difficult than normal to kill such a measure.
The bill achieves this escape for Big Tobacco by making any major FDA rules subject to section 801 of Title 5 of the United States Code (Congressional review of agency rulemaking).
The killer provision in the bill, almost certainly inserted at the insistence of Philip Morris (and for some inexplicable reason agreed to by the Campaign for Tobacco-Free Kids and other health groups), is section 915, entitled "Congressional Review Provisions." It is tucked away in fine print near the end of the bill, so that you really have to read every word of the bill to even know that it is there.
It states, simply: "In accordance with section 801 of title 5, United 8 States Code, Congress shall review, and may disapprove, any rule under this chapter that is subject to section 801."
And unfortunately, section 801 of title 5 of the United States Code states that: "A rule shall not take effect (or continue), if the Congress enacts a joint resolution of disapproval, described under section 802, of the rule."
Even more unfortunately: "A rule that does not take effect (or does not continue) under paragraph (1) may not be reissued in substantially the same form, and a new rule that is substantially the same as such a rule may not be issued, unless the reissued or new rule is specifically authorized by a law enacted after the date of the joint resolution disapproving the original rule."
In other words, the decision of Congress represents a permanent injunction against FDA issuing that rule.
To add insult to injury, section 802 of title 5 prescribes that: "In the Senate, if the committee to which is referred a joint resolution described in subsection (a) has not reported such joint resolution (or an identical joint resolution) at the end of 20 calendar days after the submission or publication date defined under subsection (b)(2), such committee may be discharged from further consideration of such joint resolution upon a petition supported in writing by 30 Members of the Senate, and such joint resolution shall be placed on the calendar."
What this means is that the resolution to disapprove an FDA tobacco rule cannot be killed in committee. It takes only 30 votes to force the resolution out of committee to the full Senate for a vote.
The icing on the cake is that: "it is at any time thereafter in order (even though a previous motion to the same effect has been disagreed to) for a motion to proceed to the consideration of the joint resolution, and all points of order against the joint resolution (and against consideration of the joint resolution) are waived. The motion is not subject to amendment, or to a motion to postpone, or to a motion to proceed to the consideration of other business. A motion to reconsider the vote by which the motion is agreed to or disagreed to shall not be in order. If a motion to proceed to the consideration of the joint resolution is agreed to, the joint resolution shall remain the unfinished business of the Senate until disposed of."
This provision blocks many of the parliamentary procedures that normally can be used to block legislation. It makes it as easy as possible for the tobacco companies to get a joint resolution of disapproval of an FDA tobacco rule enacted by Congress.
What tobacco control and public health advocates and the public need to realize is that the bill could have exempted these regulations from Congressional review. In fact, the bill does exempt from Congressional review the advertising and youth access regulations that the Secretary of Health and Human Services would be forced to promulgate (the 1996 FDA regulations). However, the remainder of the rules that FDA is given the authority to promulgate are not exempted from the Title 5, Section 801 provisions.
Obviously, Philip Morris does not feel threatened by the youth access regulations (which will do nothing) and advertising restrictions (which will do little and may also be overturned by the Supreme Court). However, a more serious threat, such as one which could threaten its profits, is subject to the Congressional review provisions.
Presumably, the simple inclusion in the legislation of a clause stating that ‘‘Section 801 of Title V of the United States Code does not apply to the regulations referred to in the Family Smoking Prevention and Tobacco Control Act" would allow FDA to regulate tobacco products without explicit Congressional review and would eliminate the short-circuited process by which Congress can override FDA rules under the current bill.
That the Campaign for Tobacco-Free Kids has stated that this legislation is "strong" and puts "protection of the public health first" is unfortunate, given their presumable knowledge that this "Philip Morris escape clause" was tucked away into the bill, apparently with the Campaign's approval.
It is inexplicable to me how any anti-smoking or public health group could support the legislation, given the presence of this clause, which clearly provides special protection to the tobacco companies at the expense of the protection of the public's health.
Even more inexplicable is how these same anti-smoking groups could refuse to consider any amendment to the legislation which would eliminate this escape clause. The Campaign for Tobacco-Free Kids and its friends supporting this legislation have repeatedly refused to entertain any changes to the legislation, even amendments that would substantially strengthen the bill and give it some teeth.
In fact, the American Cancer Society - one group that has joined Philip Morris in promoting this legislation - was quoted in the Winston-Salem Journal as stating that it would oppose any changes to the legislation: "Wendy Selig, the vice president of legislative affairs for the American Cancer Society, said her organization 'strongly supports the bill as it is written now,' and would oppose any changes. 'This bill has been vetted broadly within the health community, (and) I think what this bill sets out to do is a huge step forward for public health,' she said."
I find it very unfortunate that a public health group would be unwilling to consider any improvements in a piece of public health legislation. The appearance of this is that the American Cancer Society has agreed to some back-room deal with Philip Morris and doesn't want to strengthen the bill because they are afraid that the deal will fall through.
That is not serving the public's health. That is protecting the financial interests of Philip Morris at the expense of the public's health.
And ultimately, that's what this whole issue comes down to. The escape clause is one of numerous provisions insisted upon by Philip Morris to protect its profits and ensure that regulation of tobacco products, while real, would be limited and that any meaningful regulation could easily be blocked on political and economic grounds. The public health groups who are supporting the legislation and refusing to even consider strengthening it have essentially sold out the public's health for the financial interests of Big Tobacco.
American Medical Association Calls Low-Tar Cigarettes a Hoax, Lobbies for Bill to Require Low-Tar Cigarettes
In an article published recently by Kristin Billera of the United Press International, the president-elect of the American Medical Association (AMA) called low-tar cigarettes a huge hoax, arguing that cigarettes with lower tar yields are no safer than those with high tar yields.
According to the article: "Health advocates such as Dr. Ron Davis, president-elect of the American Medical Association, support its [the FDA tobacco legislation] passage. 'Passage of this legislation will end the cruel irony that cigarettes are the most important preventable cause of death and disease in the United States and one of the least regulated products in our society,' Davis said. Smoking causes 400,000 premature deaths each year, and lung cancer is the most fatal form of the disease. ... Selig [spokesperson for the American Cancer Society] is concerned that women in particular may be 'sucked in by a very misleading campaign' for products labeled 'light' or 'low-tar.' Lung-cancer numbers in U.S. women have remained steady, perhaps partially due to women switching from regular cigarettes to ones that are labeled as less harmful -- claims invalidated by the tobacco industry, she said. Most health officials agree that smoking 'low-tar' or 'low-nicotine' cigarettes are not any less hazardous than regular cigarettes, Davis said: 'It's like jumping out of the twenty-second floor of a building instead of the twenty-fourth.'"
The Rest of the Story
If the American Medical Association truly believes that low-tar yield cigarettes are no safer than high-tar yield cigarettes (and is like jumping out the 22nd floor instead of the 24th floor of a building), then what in the world is it doing supporting legislation whose basic regulatory framework is to require companies to produce lower-tar cigarettes?
Not only will smokers be jumping out of the 22nd floor of buildings, according to the AMA, but they will be doing so thinking that it is safer, by virtue of the fact that the FDA will be stringently regulating cigarettes and that the product will have an FDA stamp of approval.
It seems to me that something is awry here in the AMA's reasoning. If it is true that reducing the tar yield in cigarettes does nothing to make them safer, then why would we as physicians support legislation that asks the FDA to lower the tar yields of cigarettes? And why would we suggest to the public that by doing so, it will improve the safety of this product and save lives?
There is something magical in the thinking of the AMA. When the tobacco companies voluntarily reduce the tar yields of their cigarettes, they are not safer and there is no public health value. In fact, even calling the cigarettes lighter represents fraud.
But when the FDA requires tobacco companies to reduce their tar yields, the cigarettes are magically safer, lives will be saved, there is public health value to this approach, and there is no fraud committed on consumers by misleading them into thinking that a reduced tar yield implies a safer cigarette.
Moreover, the AMA and the ACS seem very concerned that smokers will be "sucked in by a very misleading campaign" that leads them to believe that there is some health value in low-tar cigarettes. Well if that is the case, then can you imagine how misled smokers will be when they are informed that cigarettes are strictly regulated by the FDA and the FDA has now approved the products they are using.
Smokers are going to assume that the product is safer. Who wouldn't, knowing that the FDA now strictly regulates them?
The tobacco companies are going to have an absolute field day with this. I would just love to be in the public relations department of Philip Morris after this bill passes. In fact, I already have some great statements that the company could make:
"Marlboro cigarettes are subject to strict regulation by the Food and Drug Administration. The ingredients, additives, and constituents of every cigarette are disclosed to the FDA and are approved by the FDA prior to being brought to you - our customers. We strictly adhere to FDA guidelines regarding the manufacturing process and constituents of the Marlboro product."
"Philip Morris is proud to be in full compliance with the Food and Drug Administration's regulations, which required a reduction in levels of a number of constituents in Marlboro cigarettes. We are happy to be in full compliance with the FDA regulations and to offer a cigarette that meets all FDA specifications. Together with the FDA, we are proud to be concerned about the health of our customers."
"Merit cigarettes, like all Philip Morris products, comply with all regulations established by the United States Food and Drug Administration. The FDA was given the authority to regulate our products in a way that, according to the largest national anti-smoking group, would "save countless lives." We are proud to be the only tobacco company to gladly submit to these regulations. We believe that saving countless lives is an admirable goal, and we are happy to be playing our part."
"Just as the Food and Drug Administration regulates the safety and effectiveness of all foods and drugs used by the public, the FDA now also approves cigarette products prior to their being made available to the public. You can now rest assured that the FDA has been apprised of every single one of the constituents in our products, and that the FDA has approved each and every one of them. No cigarette product is made available to you - our customers - without first having been officially approved by the FDA."
"Philip Morris is proud to be a long-time supporter of legislation that according to our fiercest opponents will "end special protection for the tobacco industry and protect our children and the nation's health instead." Ending special protections for our industry and protecting the health of our nation's children has long been a priority goal for Philip Morris. The legislation that we have championed will, according to our fiercest opponents, "save countless lives and improve health for generations to come by reducing tobacco use and its devastating consequences, which include cancer, heart disease, chronic obstructive pulmonary disease (COPD) and diseases that affect virtually every organ in the human body." We are glad to play our role in reducing cancer, reducing heart disease, reducing lung disease, and helping to reduce diseases that affect virtually every organ in the human body. We truly care not only about our customers, but about every organ in their body."
"Like every major national public health group, Philip Morris supports this legislation, that according to these groups, will 'protect our children, improve the nation’s health and save countless lives.' Saving countless lives is what Philip Morris is all about. We stand ready to do anything and everything that the FDA asks of us in order to save countless lives of Americans. We understand that some other tobacco companies have opposed this legislation. We, however, believe that the protection of our children and the nation's health and the effort to save countless lives should be a corporate priority, even if we will sacrifice profits due to our principled stand. We look forward to working with the FDA, and we are prepared to take any and all steps that the Agency asks of us in order to make our products safer."
"Marlboro, like all of our products, has been approved for sale and distribution in the United States by the Food and Drug Administration. The FDA has been provided with a comprehensive list of the constituents of this product and has given its approval for each of these constituents at the levels at which they exist in this package. The FDA has been directed by Congress to make its approval of our product based on consideration of what is "appropriate for the protection of the public's health." We are proud to be in full compliance with the FDA regulations. If you have any comments on our products, or any suggestions on how to make them safer, please write the Commissioner of the Food and Drug Administration."
There is little I have less tolerance for than speaking out of both sides of one's mouth. Here, the AMA is telling us that low-tar products are no safer than high-tar products, but that by requiring low-tar products, we can produce a safer product and save countless lives.
Which is it?
The rest of the story is that you can add the AMA to the list of anti-smoking and health organizations that are supporting what amounts to a transfer of the low-tar fraud from the cigarette companies to the government.
According to the article: "Health advocates such as Dr. Ron Davis, president-elect of the American Medical Association, support its [the FDA tobacco legislation] passage. 'Passage of this legislation will end the cruel irony that cigarettes are the most important preventable cause of death and disease in the United States and one of the least regulated products in our society,' Davis said. Smoking causes 400,000 premature deaths each year, and lung cancer is the most fatal form of the disease. ... Selig [spokesperson for the American Cancer Society] is concerned that women in particular may be 'sucked in by a very misleading campaign' for products labeled 'light' or 'low-tar.' Lung-cancer numbers in U.S. women have remained steady, perhaps partially due to women switching from regular cigarettes to ones that are labeled as less harmful -- claims invalidated by the tobacco industry, she said. Most health officials agree that smoking 'low-tar' or 'low-nicotine' cigarettes are not any less hazardous than regular cigarettes, Davis said: 'It's like jumping out of the twenty-second floor of a building instead of the twenty-fourth.'"
The Rest of the Story
If the American Medical Association truly believes that low-tar yield cigarettes are no safer than high-tar yield cigarettes (and is like jumping out the 22nd floor instead of the 24th floor of a building), then what in the world is it doing supporting legislation whose basic regulatory framework is to require companies to produce lower-tar cigarettes?
Not only will smokers be jumping out of the 22nd floor of buildings, according to the AMA, but they will be doing so thinking that it is safer, by virtue of the fact that the FDA will be stringently regulating cigarettes and that the product will have an FDA stamp of approval.
It seems to me that something is awry here in the AMA's reasoning. If it is true that reducing the tar yield in cigarettes does nothing to make them safer, then why would we as physicians support legislation that asks the FDA to lower the tar yields of cigarettes? And why would we suggest to the public that by doing so, it will improve the safety of this product and save lives?
There is something magical in the thinking of the AMA. When the tobacco companies voluntarily reduce the tar yields of their cigarettes, they are not safer and there is no public health value. In fact, even calling the cigarettes lighter represents fraud.
But when the FDA requires tobacco companies to reduce their tar yields, the cigarettes are magically safer, lives will be saved, there is public health value to this approach, and there is no fraud committed on consumers by misleading them into thinking that a reduced tar yield implies a safer cigarette.
Moreover, the AMA and the ACS seem very concerned that smokers will be "sucked in by a very misleading campaign" that leads them to believe that there is some health value in low-tar cigarettes. Well if that is the case, then can you imagine how misled smokers will be when they are informed that cigarettes are strictly regulated by the FDA and the FDA has now approved the products they are using.
Smokers are going to assume that the product is safer. Who wouldn't, knowing that the FDA now strictly regulates them?
The tobacco companies are going to have an absolute field day with this. I would just love to be in the public relations department of Philip Morris after this bill passes. In fact, I already have some great statements that the company could make:
"Marlboro cigarettes are subject to strict regulation by the Food and Drug Administration. The ingredients, additives, and constituents of every cigarette are disclosed to the FDA and are approved by the FDA prior to being brought to you - our customers. We strictly adhere to FDA guidelines regarding the manufacturing process and constituents of the Marlboro product."
"Philip Morris is proud to be in full compliance with the Food and Drug Administration's regulations, which required a reduction in levels of a number of constituents in Marlboro cigarettes. We are happy to be in full compliance with the FDA regulations and to offer a cigarette that meets all FDA specifications. Together with the FDA, we are proud to be concerned about the health of our customers."
"Merit cigarettes, like all Philip Morris products, comply with all regulations established by the United States Food and Drug Administration. The FDA was given the authority to regulate our products in a way that, according to the largest national anti-smoking group, would "save countless lives." We are proud to be the only tobacco company to gladly submit to these regulations. We believe that saving countless lives is an admirable goal, and we are happy to be playing our part."
"Just as the Food and Drug Administration regulates the safety and effectiveness of all foods and drugs used by the public, the FDA now also approves cigarette products prior to their being made available to the public. You can now rest assured that the FDA has been apprised of every single one of the constituents in our products, and that the FDA has approved each and every one of them. No cigarette product is made available to you - our customers - without first having been officially approved by the FDA."
"Philip Morris is proud to be a long-time supporter of legislation that according to our fiercest opponents will "end special protection for the tobacco industry and protect our children and the nation's health instead." Ending special protections for our industry and protecting the health of our nation's children has long been a priority goal for Philip Morris. The legislation that we have championed will, according to our fiercest opponents, "save countless lives and improve health for generations to come by reducing tobacco use and its devastating consequences, which include cancer, heart disease, chronic obstructive pulmonary disease (COPD) and diseases that affect virtually every organ in the human body." We are glad to play our role in reducing cancer, reducing heart disease, reducing lung disease, and helping to reduce diseases that affect virtually every organ in the human body. We truly care not only about our customers, but about every organ in their body."
"Like every major national public health group, Philip Morris supports this legislation, that according to these groups, will 'protect our children, improve the nation’s health and save countless lives.' Saving countless lives is what Philip Morris is all about. We stand ready to do anything and everything that the FDA asks of us in order to save countless lives of Americans. We understand that some other tobacco companies have opposed this legislation. We, however, believe that the protection of our children and the nation's health and the effort to save countless lives should be a corporate priority, even if we will sacrifice profits due to our principled stand. We look forward to working with the FDA, and we are prepared to take any and all steps that the Agency asks of us in order to make our products safer."
"Marlboro, like all of our products, has been approved for sale and distribution in the United States by the Food and Drug Administration. The FDA has been provided with a comprehensive list of the constituents of this product and has given its approval for each of these constituents at the levels at which they exist in this package. The FDA has been directed by Congress to make its approval of our product based on consideration of what is "appropriate for the protection of the public's health." We are proud to be in full compliance with the FDA regulations. If you have any comments on our products, or any suggestions on how to make them safer, please write the Commissioner of the Food and Drug Administration."
There is little I have less tolerance for than speaking out of both sides of one's mouth. Here, the AMA is telling us that low-tar products are no safer than high-tar products, but that by requiring low-tar products, we can produce a safer product and save countless lives.
Which is it?
The rest of the story is that you can add the AMA to the list of anti-smoking and health organizations that are supporting what amounts to a transfer of the low-tar fraud from the cigarette companies to the government.
Friday, March 02, 2007
The Big Fraud: Light Cigarettes or Anti-Smoking Groups' Nicotine Regulation Propaganda?
In the DOJ tobacco case, cigarette manufacturers were found guilty of fraud for implying to the public that there is some health value in cigarettes with lower levels of nicotine. The truth is that smokers tend to compensate by increasing their puff intensity and cigarette consumption to make up for lower nicotine delivery, thus keeping their nicotine dosage the same. Thus, the suggestion that there is health value in low-nicotine cigarettes is false.
For this miscommunication, the cigarette companies have been labeled as racketeers, guilty of defrauding the American people, and they have been ordered not only to never again imply that low-nicotine cigarettes have some health value, but to not even use terms like "light" or "mild" that could possibly be construed as suggesting that these lower-nicotine products are safer in some way.
Now come an anti-smoking researcher from Harvard, a prominent tobacco control expert on nicotine addiction and tobacco products, and the Campaign for Tobacco-Free Kids and its coalition of "every major national public health group," suggesting to the public that by allowing the FDA to reduce nicotine levels in cigarettes, the public's health will be improved.
In other words, implying that low-nicotine cigarettes have some health value.
The Rest of the Story
The rest of the story, which you won't read about in newspapers, is that these prominent tobacco control researchers and major anti-smoking groups are making the exact same fraudulent claim for which the tobacco companies were found guilty of violating federal law!
What is fraud for the tobacco companies is apparently a favored approach to the tobacco problem for major anti-smoking groups.
And the deception of the public is not just theoretical - it is actually happening. I am watching it happen before my own eyes.
Just read the newspaper editorials and columns being written about this issue. You will see that the media have been successfully deceived by the anti-smoking groups. They actually believe that reducing nicotine levels is the answer to the problem.
Take Jim Hightower's column published yesterday in the Austin Chronicle.
For this miscommunication, the cigarette companies have been labeled as racketeers, guilty of defrauding the American people, and they have been ordered not only to never again imply that low-nicotine cigarettes have some health value, but to not even use terms like "light" or "mild" that could possibly be construed as suggesting that these lower-nicotine products are safer in some way.
Now come an anti-smoking researcher from Harvard, a prominent tobacco control expert on nicotine addiction and tobacco products, and the Campaign for Tobacco-Free Kids and its coalition of "every major national public health group," suggesting to the public that by allowing the FDA to reduce nicotine levels in cigarettes, the public's health will be improved.
In other words, implying that low-nicotine cigarettes have some health value.
The Rest of the Story
The rest of the story, which you won't read about in newspapers, is that these prominent tobacco control researchers and major anti-smoking groups are making the exact same fraudulent claim for which the tobacco companies were found guilty of violating federal law!
What is fraud for the tobacco companies is apparently a favored approach to the tobacco problem for major anti-smoking groups.
And the deception of the public is not just theoretical - it is actually happening. I am watching it happen before my own eyes.
Just read the newspaper editorials and columns being written about this issue. You will see that the media have been successfully deceived by the anti-smoking groups. They actually believe that reducing nicotine levels is the answer to the problem.
Take Jim Hightower's column published yesterday in the Austin Chronicle.
Hightower states: "There are easy steps the corporations could take to reduce the addictive and carcinogenic power of their products. Far from reducing the killer contents, however, cigarette makers have deliberately been juicing up the potency of their cancer sticks. A recent study by the Harvard School of Public Health finds that the amount of addictive nicotine that cigarettes pump into the lungs of smokers jumped by 11% from 1998 to 2005. With no regulators to restrain them, the corporations have merrily added higher-nicotine tobacco to cigarettes... In other words, they have carelessly made their products a greater danger. This year, however, the new democratic majority in Congress has a chance to rein in these runaway greedheads by putting tobacco products under FDA regulation."
Clearly, Hightower is suggesting that by lowering levels of nicotine in cigarettes, the corporations would reduce the addictive power of their products and improve the public's health. He has fallen for the Campaign for Tobacco-Free Kids' propaganda hook, line, and sinker.
As I have pointed out repeatedly, lowering the nicotine levels in cigarettes would be the worst thing we could do. It would be a public health disaster of unprecedented proportions. It would force smokers to increase the amount they smoke (in order to maintain the same dosage of nicotine), thereby increasing tar delivery and the resulting carcinogenic and chronic lung destruction effects.
If we do anything (short of simply eliminate the nicotine), we should actually require very high levels of nicotine in cigarettes. This would do two things: (1) decrease cigarette consumption and the resulting health effects; and (2) make cigarettes basically unpalatable for kids.Such a measure would likely decrease youth smoking substantially for this latter reason.
As a second example, take this recent editorial in the Toledo Blade. It states: "Regulating nicotine in tobacco would be a logical step, inasmuch as federal law already allows its regulation in nicotine gum, patches, and nasal sprays. Moreover, scientific studies indicate the tobacco companies have been loading up their products with the drug even as consumers are smoking less. The school of public health at Harvard University recently confirmed a survey by Massachusetts state researchers showing that nicotine levels in cigarettes rose by about 11 percent from 1997 to 2005. The survey, based on statistics submitted to the state by cigarette companies, indicates that the industry wants to keep its customers hooked, even though many now recognize the dangers of smoking and would like to quit. ... It's time to take the long-overdue step of regulating nicotine and start saving lives instead of snuffing them out."
Again -- hook, line, and sinker.
By regulating nicotine in tobacco, the editorial is talking about reducing nicotine in cigarettes. Rather than "saving lives," such a move would indeed "snuff them out." It would subject smokers to higher tar delivery, because they would tend to compensate for the reduced nicotine yields by smoking more.
To demonstrate how ridiculous is the logic behind the Campaign for Tobacco-Free Kids' proposal, the cigarette companies have made a drastic reduction in the tar yields of their cigarettes over the past several decades. In 1977 (30 years ago), 77.3% of all cigarettes smoked had a tar yield of greater than 15 mg. Today, only about 15% of all cigarettes smoked have a tar yield of greater than 15 mg.
But you don't see the anti-smoking groups praising the tobacco companies for producing a safer product. You don't see anyone suggesting that because of these drastic reductions in tar yields, cigarettes are safer today then they were 30 years ago. I am not aware of any tobacco control colleague of mine who has argued that these drastic reductions in tar yields over the past 30 years has resulted in a safer cigarette and therefore, saved "countless lives." I'm not even aware of any tobacco control colleague who has argued that these drastic reductions in the levels of smoke constituents have resulted in saving a single life.
And if the tobacco companies did claim that these drastic reductions in tar levels had resulted in a safer cigarette, you can bet that we in tobacco control would blast them and this would be further evidence of their fraud. In fact, this is exactly what did happen.
But what the public needs to realize is that this is precisely the regulatory framework that the major anti-smoking groups are proposing! Let's force the companies to reduce the levels of smoke constituents, and that will produce a safer product. Well if reducing the overall tar yields drastically over the last 30 years didn't produce a safer product, then what good is taking out or reducing the levels of a few of the constituents?
Even more striking is the fact that cigarette companies have substantially reduced the nicotine yields of their cigarettes over the past 30 years. In 1970, the average nicotine yield of cigarettes smoked in the U.S. was 1.31 mg. Today, it is down to below 0.9 mg.
There has been a 31% reduction in nicotine levels in cigarettes over the past 3 decades!!!
But none of the anti-smoking groups which are supporting the FDA legislation are applauding the cigarette companies for reducing these nicotine yields. (We only attack them when we find short-term increases in these yields.) None of these anti-smoking groups are suggesting that there has been any health value, either in terms of a safer cigarette or reduced addiction of young people, because of these substantial changes.
Yet now, these anti-smoking groups are trying to convince us that if the FDA forces the companies to reduce the nicotine levels, it will reduce addiction and save lives.
So let's get this straight. When the cigarette companies voluntarily reduce the nicotine levels in their cigarettes:
- it is of no health value;
- it is dastardly and deceptive; and
- it is fraud to even let anyone know that the nicotine levels are lower.
But if the government forces the companies to reduce the nicotine levels of their cigarettes:
- it is of great health value (it will save "countless" lives);
- it represents meaningful regulation to protect the public's health; and
- it is fine to let the public know that nicotine levels are going down even though there is no proof it will protect them and there is a lot of evidence that this will hurt them.
The double standard in tobacco control is just astounding.
You don't hear the Campaign for Tobacco-Free Kids or its cohorts in the deception of the American public telling us that Marlboro Lights are safer or less addictive than full-strength Marlboros because the nicotine and tar levels are much lower. You don't hear these groups praising Philip Morris for taking the effort to produce a lower-yield cigarette and calling it a step in the right direction, and urging the company to keep lowering their nicotine yields and produce Marlboro Very Lights, Marlboro Ultra Very Lights, Marlboro Extremely Lights, and eventually, Marlboro Totally Fricking Lights.
Instead, these anti-smoking groups are telling us that it is fraudulent to uses the terms lights or extremely lights or totally fricking light and that these terms are completely meaningless and need to be abandoned.
Yet the regulatory scheme that these groups are supporting purports to save countless lives and reduce the addictive potential of cigarettes precisely by forcing the companies to produce Marlboro Very Lights.
All I can tell you in conclusion is that after 21 years in tobacco control, I am coming to the conclusion that the movement (at least its leading organizations) is becoming totally fricking insane.
Thursday, March 01, 2007
Major Anti-Smoking Groups and their Politicians Get High Marks for Meaningless and Deceptive Propaganda
In an unusual change of pace from my past criticism of the major anti-smoking groups for their role in deceiving the public about the details regarding the proposed FDA tobacco legislation, I am today awarding these groups, and the politicians who are working hand-in-hand with them, a grade of A+ on my meaningless and deceptive propaganda report card.
The Rest of the Story
Leading the charge and making a substantial contribution to the A+ grade is Senator Edward Kennedy, who came up with this whopper of public deception:
"If Congress fails to act and smoking continues at its current rate, more than 6 million of today's children will ultimately die from tobacco-induced disease."
Of course, this statement implies that by Congress acting, and enacting the proposed legislation, Congress will prevent these 6 million kids from dying from tobacco-induced disease. It indicates that the legislation will reduce smoking prevalence so that smoking does not continue at its current rate.
But the truth is that the proposed legislation will not reduce smoking prevalence, and it might even increase it. Supporters of the legislation are banking on strict advertising regulations to curtail youths' exposure to cigarette advertising, and in turn, to reduce smoking initiation. However, as I explained yesterday, the Supreme Court is virtually certain to find unconstitutional any advertising restrictions that might result in a meaningful reduction in youth exposure to cigarette advertising.
On the other hand, by giving tobacco products an FDA seal of approval, public perception of the dangers of smoking is likely to be undermined. This would be expected to lead to an increase, not a decrease, in smoking prevalence.
The second whopper of public deception goes to the Campaign for Tobacco-Free Kids, which in its Senate testimony tried to make Congress believe that there is no opposition to the proposed legislation within the public health community:
"It [Senate bill 625] has been endorsed by every major national public health organization... ."
Clearly, the Campaign is trying to convince Congress that the legislation is universally supported by public health practitioners. The truth, however, is that the public health community is deeply divided on this issue. A large number of public health organizations and advocates vehemently oppose the legislation. In fact, I personally am working with a coalition of at least two dozen public health advocates to try to derail the legislation.
To tell Congress that every major national public health organization has endorsed the legislation is close to a complete lie. What saves it from being a complete lie is the word "major." By leaving room to argue that they interpret "major" in their own particular way, the Campaign spares itself from perjury in front of Congress.
But would it really be accurate and forthright to state, for example, that the American Association of Public Health Physicians (AAPHP) is not a major national public health group? The AAPHP has helped lead the fight against the FDA tobacco legislation for the past two years.
The AAPHP's mission statement makes it clear that this is indeed a major national public health organization: "AAPHP will expand its role as an influential national organization. Public Health physicians will, in greater numbers, convene under the AAPHP banner to develop their policy and advocacy plans and strategies. AMA, ACPM, other physician and public health organizations, and others, will increasingly seek AAPHP assistance in their policy deliberations. Working together we will help improve the health information of the nation through effective application of public health principles, and the development of data-driven population based services."
Perhaps the Campaign's testimony is not an outright lie - but if it isn't a lie, then it is a downright insult to the major national organization of public health physicians in this country, who have now been discounted as being a major national public health organization. Take that, public health physicians! You are not important. Your organization, while national and related to public health, is not major. You - public health physicians - are just a minor player in our public health system. So go back to your doctor's offices. No one needs to know about your position on this legislation (since you're against it).
I can kind of see why proponents of this legislation need to resort to wild, grandiose, exaggerated, meaningless and deceptive propaganda: because when you actually talk about the specific merits of the proposed legislation, you realize that it is actually an absurd regulatory framework that would institutionalize continued deception of American consumers and lead to devastating effects on the public's health. But it would protect Philip Morris' profits.
Who's deceiving who here?
In some ways, the deception by the anti-smoking groups supporting this legislation is greater than that of the tobacco companies over the past years. At least with smoking, it was pretty obvious that the companies were lying or stretching the truth. Here, unless you read the actual bill for yourself (which few people are going to do), you'd have no way of knowing that our major anti-smoking groups and the politicians standing with them are deceiving you.
I guess it is perfectly honest for me to state that every major national public health organization is deceiving the public about the proposed FDA legislation. Since every major national public health organization has apparently endorsed the legislation and since the rhetoric regarding the legislation is deceiving the American people, my contention seems perfectly valid.
In conclusion, then, every major national public health organization in the United States is part of a campaign that is deceiving the public about the proposed FDA legislation.
The Rest of the Story
Leading the charge and making a substantial contribution to the A+ grade is Senator Edward Kennedy, who came up with this whopper of public deception:
"If Congress fails to act and smoking continues at its current rate, more than 6 million of today's children will ultimately die from tobacco-induced disease."
Of course, this statement implies that by Congress acting, and enacting the proposed legislation, Congress will prevent these 6 million kids from dying from tobacco-induced disease. It indicates that the legislation will reduce smoking prevalence so that smoking does not continue at its current rate.
But the truth is that the proposed legislation will not reduce smoking prevalence, and it might even increase it. Supporters of the legislation are banking on strict advertising regulations to curtail youths' exposure to cigarette advertising, and in turn, to reduce smoking initiation. However, as I explained yesterday, the Supreme Court is virtually certain to find unconstitutional any advertising restrictions that might result in a meaningful reduction in youth exposure to cigarette advertising.
On the other hand, by giving tobacco products an FDA seal of approval, public perception of the dangers of smoking is likely to be undermined. This would be expected to lead to an increase, not a decrease, in smoking prevalence.
The second whopper of public deception goes to the Campaign for Tobacco-Free Kids, which in its Senate testimony tried to make Congress believe that there is no opposition to the proposed legislation within the public health community:
"It [Senate bill 625] has been endorsed by every major national public health organization... ."
Clearly, the Campaign is trying to convince Congress that the legislation is universally supported by public health practitioners. The truth, however, is that the public health community is deeply divided on this issue. A large number of public health organizations and advocates vehemently oppose the legislation. In fact, I personally am working with a coalition of at least two dozen public health advocates to try to derail the legislation.
To tell Congress that every major national public health organization has endorsed the legislation is close to a complete lie. What saves it from being a complete lie is the word "major." By leaving room to argue that they interpret "major" in their own particular way, the Campaign spares itself from perjury in front of Congress.
But would it really be accurate and forthright to state, for example, that the American Association of Public Health Physicians (AAPHP) is not a major national public health group? The AAPHP has helped lead the fight against the FDA tobacco legislation for the past two years.
The AAPHP's mission statement makes it clear that this is indeed a major national public health organization: "AAPHP will expand its role as an influential national organization. Public Health physicians will, in greater numbers, convene under the AAPHP banner to develop their policy and advocacy plans and strategies. AMA, ACPM, other physician and public health organizations, and others, will increasingly seek AAPHP assistance in their policy deliberations. Working together we will help improve the health information of the nation through effective application of public health principles, and the development of data-driven population based services."
Perhaps the Campaign's testimony is not an outright lie - but if it isn't a lie, then it is a downright insult to the major national organization of public health physicians in this country, who have now been discounted as being a major national public health organization. Take that, public health physicians! You are not important. Your organization, while national and related to public health, is not major. You - public health physicians - are just a minor player in our public health system. So go back to your doctor's offices. No one needs to know about your position on this legislation (since you're against it).
I can kind of see why proponents of this legislation need to resort to wild, grandiose, exaggerated, meaningless and deceptive propaganda: because when you actually talk about the specific merits of the proposed legislation, you realize that it is actually an absurd regulatory framework that would institutionalize continued deception of American consumers and lead to devastating effects on the public's health. But it would protect Philip Morris' profits.
Who's deceiving who here?
In some ways, the deception by the anti-smoking groups supporting this legislation is greater than that of the tobacco companies over the past years. At least with smoking, it was pretty obvious that the companies were lying or stretching the truth. Here, unless you read the actual bill for yourself (which few people are going to do), you'd have no way of knowing that our major anti-smoking groups and the politicians standing with them are deceiving you.
I guess it is perfectly honest for me to state that every major national public health organization is deceiving the public about the proposed FDA legislation. Since every major national public health organization has apparently endorsed the legislation and since the rhetoric regarding the legislation is deceiving the American people, my contention seems perfectly valid.
In conclusion, then, every major national public health organization in the United States is part of a campaign that is deceiving the public about the proposed FDA legislation.
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