Monday, July 25, 2011
Thursday, July 21, 2011
NEJM Perspective Article Concludes that Electronic Cigarettes are Likely Ineffective for Smoking Cessation, But Without Any Supportive Evidence
Article Effectively Encourages Ex-Smokers Who Quit Using Electronic Cigarettes to Return to Regular Cigarette Smoking
In a Perspective article published today in the New England Journal of Medicine, Cobb and Abrams conclude that because of its ineffective nicotine delivery, electronic cigarettes are unlikely to be useful in attempts to quit smoking.
(see: Cobb NK, Abrams DB. E-Cigarette or Drug-Delivery Device? Regulating Novel Nicotine Products. New England Journal of Medicine 2011. Published online ahead of print on July 21, 2011).
According to the article: "testing of users in laboratory settings revealed minimal blood nicotine concentrations. Marketing claims aside, the devices tested did not efficiently deliver nicotine, much less deliver it into the arterial blood as tobacco smoke does. Smokers attempting to use e-cigarettes for smoking cessation will most likely find them ineffective; indeed, their use may instead perpetuate smokers' addiction."
The article argues that there are already many effective treatments for smoking cessation available: "In reality, both smokers and e-cigarette users have many alternatives: multiple nicotine products, approved, regulated, and deemed to be safe and effective by the FDA, are already widely available (in addition to other effective cessation tools, such as varenicline, bupropion, telephone quit-lines, and Web-based services)."
The article advises physicians to recommend against the use of electronic cigarettes: "clinicians should advise patients wishing to use nicotine to stick to the FDA-regulated forms, such as patches, gum, lozenges, nasal spray — or even, perhaps, the existing FDA-approved inhaler."
The Rest of the Story
The article is problematic for two major reasons.
First, it draws a conclusion -- that electronic cigarettes are unlikely to be effective in helping smokers quit -- based on no supporting evidence. In fact, the article ignores the overwhelming number of reports from actual individuals who have used electronic cigarettes successfully to quit smoking. Instead, it relies on a single study which under unrealistic conditions, found ineffective delivery of nicotine from an electronic cigarette among novice users.
The article's perspective is flawed because it only recognizes one aspect of addiction to cigarettes: the pharmacologic addiction to nicotine. It ignores the fact that there is a strong behavioral aspect to the addiction. The physical stimuli, the various acts associated with smoking, the social factors, are all part of the addiction. In fact, electronic cigarettes are effective for many smokers specifically because they mimic the behavioral act of smoking and thus address the behavioral and not merely the pharmacologic aspect of the addiction.
Instead of concluding that electronic cigarettes are unlikely to help smokers quit, the article should instead have noted how remarkable it is that a product which appears to deliver nicotine relatively ineffectively has been so effective in helping many smokers to quit. So much so that there are internet forums with thousands of vapers who testify to the effectiveness of these devices in keeping them off cigarettes completely, many of them for more than a year. With technological refinements that would improve nicotine delivery, the effectiveness of the product will only improve.
It is surprising that the article would draw a conclusion regarding the ineffectiveness of electronic cigarettes in helping smokers quit without actually reviewing the substantial evidence -- put forward by literally hundreds of ex-smokers -- that the electronic cigarette is what enabled them to quit smoking. In order for Cobb and Abrams' conclusion to be true, these hundreds of electronic cigarette users must apparently be lying.
It is interesting that while the authors completely discount hundreds of reports of the effectiveness of electronic cigarettes for complete smoking cessation, they are willing to put out dire warnings about the dangers of the product in the absence of a single reported case of nicotine toxicity - or any other serious adverse effect - caused by electronic cigarettes, despite their use by more than a million people over the past four years, and despite the failure of the FDA to report any serious adverse effects for two years following its urging of vapers to report such effects to the agency.
The second problem with the article is that it makes what I feel is an irresponsible medical recommendation: that ex-smokers who have quit successfully using the electronic cigarette discontinue the use of these devices and switch over to an FDA-approved therapy, like the nicotine patch.
The rest of the story is that the majority of these successful ex-smokers have tried FDA-approved therapies and failed. This is precisely why they have given electronic cigarettes a try. People do not generally pick up an electronic cigarette for $40 to $90 in a first attempt to quit smoking. Usually, they try the FDA-approved therapies first, get frustrated that they don't work well, and then decide to try an unconventional approach. It is almost undoubtedly true that if vapers stopped using electronic cigarettes and switched over to the nicotine patch or gum, most of them would end up smoking cigarettes within hours to days.
This is why I call it irresponsible advice: the result would be literally thousands of ex-smokers returning to regular cigarette smoking. It would be essentially a public health disaster. The complete reversal of tremendous health gains that these vapers have already realized. What a shame it would be to have thousands of these ex-smokers negate their success in quitting smoking and return to the analog cigarettes because of some unsupported and ill-thought-out advice that somehow they are worse off being ex-smokers on e-cigarettes than current smokers on Marlboros.
But the real shame of this story is that the ill advice is not coming from individuals who are objective and financially unconflicted. It is coming from authors who I believe have financial conflicts of interest that could be perceived as potentially biasing them to protect the profits of traditional smoking cessation approaches.
Dr. Cobb is a paid consultant to a company that makes its profits based on an internet smoking cessation site which heavily promotes smoking cessation drugs: "Dr Cobb is a consultant to Healthways Inc, the current owner of the QuitNet system." Thus, he is conflicted because to the extent that the use of electronic cigarettes presents a different pathway to cessation than the traditional one - the use of a smoking cessation internet site, medication, online support, etc. - e-cigarettes may represent a threat to the profits of Healthways. In this light, it is perhaps not surprising that "Web-based services" are called out in the article as an existing smoking strategy that should be relied upon instead of electronic cigarettes.
Dr. Abrams has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer. Dr. Abrams also reports having served as a senior scientific advisor for Johnson & Johnson. It is difficult to find a pharmaceutical company involved in smoking cessation drugs that Dr. Abrams has not had an association with over the years.
This is not to criticize him; the research has made important contributions. It is simply to make note of the financial conflicts of interest that are present with respect to his views on electronic cigarettes, a major threat to the profits of these very same pharmaceutical companies.
The bottom line is that the article draws a major conclusion which lacks supportive evidence and which ignores substantial evidence, that it advances a piece of medical advice which is ill-chosen and could be harmful to many people, and that both of these problems appear in the setting of substantial financial conflicts of interest.
Wednesday, July 20, 2011
TPSAC Has Second Chance to Make Menthol Cigarette Recommendation to FDA But Declines; FDA Will Now Have to Do the Work on Its Own
Earlier this year, I criticized the Tobacco Products Scientific Advisory Committee (TPSAC) for failing, in its menthol cigarette report, to make a recommendation to the FDA regarding what action the agency should take. Recently, the Committee had a second chance to make a recommendation. Of its own initiative, the Committee requested an opportunity to issue an amended report with a number of changes.
When I first learned that TPSAC wanted to issue an amended report, I considered the possibility that maybe the committee took to heart the nation's reaction -- that the report did not in fact include any recommendation that the FDA ban or proceed to ban menthol cigarettes -- and decided to definitively clarify the issue. The chair of the committee had stated in a newspaper article, in response to my criticism, that the committee did in fact make a clear recommendation. I thought that perhaps the committee was taking advantage of this opportunity to make its recommendation clear to the public and to the FDA.
No such luck, however. The changes in the report were minor, and they did not alter the report's failure to deliver a recommendation on what policy the FDA should adopt regarding menthol cigarettes.
The report's "recommendation" remained a self-evident conclusion rather than a recommendation: removing menthol cigarettes from the market would benefit the public's health.
As I explained earlier, this is a conclusion, not a recommendation. I could just as easily conclude that removing all cigarettes from the market would benefit the public's health. That may be true, but it does not amount to a recommendation that cigarette sales be prohibited. One can believe that removing cigarettes from the market would benefit the public's health and still be free to either recommend a ban on cigarettes or not to recommend such a ban.
Thus, the simple statement that removing menthol cigarettes from the market would benefit the public's health does not amount to a recommendation either way. In fact, the report goes on to insist that it has no particular position on the issue or advice to the FDA, other than that the agency be sure to consider the potential contraband effects of a menthol ban if it does consider such a policy.
The Rest of the Story
The rest of the story is that, once again, the TPSAC has shirked its Congressionally-mandated responsibility to weigh the costs and benefits of a menthol cigarette ban and instead, it has again punted the issue right back to the FDA. This leaves the agency with little choice other than to initiate its own review of the issue and make its own decision. In fact, this is precisely what the agency announced it will now do. Thus, the TPSAC's report and deliberations were largely a waste of time and resources, as I argued previously.
The TPSAC has played perfectly into Philip Morris' hands by displaying the utmost of bureaucratic piddling and diddling. Knowing that it would be almost impossible to get a menthol ban promulgated via administrative actions by federal agencies, Philip Morris happily agreed to a compromise Tobacco Act that exempted menthol from its flavoring ban but delegated the advisory committee to study the issue. Philip Morris knew full well that the chances of a menthol ban being implemented by regulation, rather than by legislation, are minimal.
Now that TPSAC has squandered its opportunity to direct the FDA one way or another, the chances of a menthol cigarette ban become even lower.
And it is now eminently clear that the lack of a recommendation by the TPSAC was not a simple omission or oversight; it was an intentional act of bureaucratic inertia and weakness.
When I first learned that TPSAC wanted to issue an amended report, I considered the possibility that maybe the committee took to heart the nation's reaction -- that the report did not in fact include any recommendation that the FDA ban or proceed to ban menthol cigarettes -- and decided to definitively clarify the issue. The chair of the committee had stated in a newspaper article, in response to my criticism, that the committee did in fact make a clear recommendation. I thought that perhaps the committee was taking advantage of this opportunity to make its recommendation clear to the public and to the FDA.
No such luck, however. The changes in the report were minor, and they did not alter the report's failure to deliver a recommendation on what policy the FDA should adopt regarding menthol cigarettes.
The report's "recommendation" remained a self-evident conclusion rather than a recommendation: removing menthol cigarettes from the market would benefit the public's health.
As I explained earlier, this is a conclusion, not a recommendation. I could just as easily conclude that removing all cigarettes from the market would benefit the public's health. That may be true, but it does not amount to a recommendation that cigarette sales be prohibited. One can believe that removing cigarettes from the market would benefit the public's health and still be free to either recommend a ban on cigarettes or not to recommend such a ban.
Thus, the simple statement that removing menthol cigarettes from the market would benefit the public's health does not amount to a recommendation either way. In fact, the report goes on to insist that it has no particular position on the issue or advice to the FDA, other than that the agency be sure to consider the potential contraband effects of a menthol ban if it does consider such a policy.
The Rest of the Story
The rest of the story is that, once again, the TPSAC has shirked its Congressionally-mandated responsibility to weigh the costs and benefits of a menthol cigarette ban and instead, it has again punted the issue right back to the FDA. This leaves the agency with little choice other than to initiate its own review of the issue and make its own decision. In fact, this is precisely what the agency announced it will now do. Thus, the TPSAC's report and deliberations were largely a waste of time and resources, as I argued previously.
The TPSAC has played perfectly into Philip Morris' hands by displaying the utmost of bureaucratic piddling and diddling. Knowing that it would be almost impossible to get a menthol ban promulgated via administrative actions by federal agencies, Philip Morris happily agreed to a compromise Tobacco Act that exempted menthol from its flavoring ban but delegated the advisory committee to study the issue. Philip Morris knew full well that the chances of a menthol ban being implemented by regulation, rather than by legislation, are minimal.
Now that TPSAC has squandered its opportunity to direct the FDA one way or another, the chances of a menthol cigarette ban become even lower.
And it is now eminently clear that the lack of a recommendation by the TPSAC was not a simple omission or oversight; it was an intentional act of bureaucratic inertia and weakness.
Tuesday, July 19, 2011
Charleston Gazette Article Highlights Criticism of Conclusions of Kanawha County Heart Attack Study
An article in the Charleston Gazette highlights my criticism of the Kanawha County study which concluded that the county's smoking ban resulted in a sustained decline in heart attacks during the period 2000-2008.
Here are the details: Kanawha County (West Virginia) had virtually no clean indoor air protection in place until January 1, 2004. Prior to that time, smoking was allowed in most workplaces and in up to 50% of designated seating in restaurants. As of January 1, 2004, smoking was prohibited entirely in workplaces, including restaurants.The investigators examined hospital admission rates for acute coronary syndrome from 2000 through 2008, thus including four years prior to the smoking ban and four years following the smoking ban. Had the smoking ban led to a decline in acute coronary syndrome admissions, one would have seen such a decline during the 2004-2008 period compared to the 2000-2004 period.
The data, however, show no such decline. Instead, the data show a steady decline in acute coronary syndrome (ACS) rates that is consistent throughout the study period and does not accelerate after the implementation of the smoking ban. The study therefore demonstrates that a stringent smoking ban implemented in Kanawha County was not associated with any significant change in hospital admissions for acute coronary events, refuting the conclusions of other studies which reported such effects.
Curiously, this is not what the study authors chose to report in their conclusions. As if pulling a silver lining out of a dark cloud, the investigators instead conclude as follows: "In the presence of a CIAR [clean indoor air regulation], a consistent decline in incidence of hospital admissions for ACS can be demonstrated." The same conclusion is reiterated later in the paper: "In conclusion, our results demonstrate that from 2000 through 2008, the rate of hospital admissions for ACS has consistently declined in Kanawha County in the presence of an existing CIAR."
I argued that to associate the decline in ACS admission rates during this time period with the almost non-existent smoking restrictions is ludicrous. First of all, the paper does not show any change in the admission rate from before to after the weak county regulations. They had in fact been in effect since 1995. So unless the paper went back to about 1990, it could not possibly draw conclusions about the relationship between the county regulation passed in 1995 and any change in ACS admission rates.
Furthermore, the so-called clean indoor air regulation in the county is meaningless. Restaurants were allowed to designate up to 50% of their seating for smoking. That isn't a smoking ban. It's essentially no regulation. In almost every other study of this kind, such a regulation would be considered the absence of a smoking ban. Obviously, a 50% designated smoking area policy is not going to protect customers from secondhand smoke exposure. This has been proven in multiple studies.
I concluded that this story shows how seriously the quality of tobacco control science has degraded. I also offered a $100 reward to any anti-smoking group that had the integrity to report the actual study findings. Needless to say, there were no takers and my money remains safe.
The Rest of the Story
I think this article does a fine job of articulating this story and describing why it is that the conclusions of the study are unsupported by the actual study findings.
For example, the article astutely points out that: "The authors of the study do state in their findings that no significant changes were recorded "between, before and after the removal of smoking areas in restaurants," in 2004.
If this is the case, then how can the article possibly conclude that the smoking ban (which was implemented in 2004) led to a decline in the rate of acute coronary syndrome admissions?
The answer is: it can't. That it draws this conclusion anyway is essentially a sleight of hand. It is scientifically faulty at best and disingenuous at worst.
Not unexpectedly, for being willing to criticize anti-smoking research on scientific grounds, I was accused (in the comments section) of being a paid tobacco industry lobbyist. Well then, I guess I'll be excitedly anticipating the receipt of my next paycheck.
Here are the details: Kanawha County (West Virginia) had virtually no clean indoor air protection in place until January 1, 2004. Prior to that time, smoking was allowed in most workplaces and in up to 50% of designated seating in restaurants. As of January 1, 2004, smoking was prohibited entirely in workplaces, including restaurants.The investigators examined hospital admission rates for acute coronary syndrome from 2000 through 2008, thus including four years prior to the smoking ban and four years following the smoking ban. Had the smoking ban led to a decline in acute coronary syndrome admissions, one would have seen such a decline during the 2004-2008 period compared to the 2000-2004 period.
The data, however, show no such decline. Instead, the data show a steady decline in acute coronary syndrome (ACS) rates that is consistent throughout the study period and does not accelerate after the implementation of the smoking ban. The study therefore demonstrates that a stringent smoking ban implemented in Kanawha County was not associated with any significant change in hospital admissions for acute coronary events, refuting the conclusions of other studies which reported such effects.
Curiously, this is not what the study authors chose to report in their conclusions. As if pulling a silver lining out of a dark cloud, the investigators instead conclude as follows: "In the presence of a CIAR [clean indoor air regulation], a consistent decline in incidence of hospital admissions for ACS can be demonstrated." The same conclusion is reiterated later in the paper: "In conclusion, our results demonstrate that from 2000 through 2008, the rate of hospital admissions for ACS has consistently declined in Kanawha County in the presence of an existing CIAR."
I argued that to associate the decline in ACS admission rates during this time period with the almost non-existent smoking restrictions is ludicrous. First of all, the paper does not show any change in the admission rate from before to after the weak county regulations. They had in fact been in effect since 1995. So unless the paper went back to about 1990, it could not possibly draw conclusions about the relationship between the county regulation passed in 1995 and any change in ACS admission rates.
Furthermore, the so-called clean indoor air regulation in the county is meaningless. Restaurants were allowed to designate up to 50% of their seating for smoking. That isn't a smoking ban. It's essentially no regulation. In almost every other study of this kind, such a regulation would be considered the absence of a smoking ban. Obviously, a 50% designated smoking area policy is not going to protect customers from secondhand smoke exposure. This has been proven in multiple studies.
I concluded that this story shows how seriously the quality of tobacco control science has degraded. I also offered a $100 reward to any anti-smoking group that had the integrity to report the actual study findings. Needless to say, there were no takers and my money remains safe.
The Rest of the Story
I think this article does a fine job of articulating this story and describing why it is that the conclusions of the study are unsupported by the actual study findings.
For example, the article astutely points out that: "The authors of the study do state in their findings that no significant changes were recorded "between, before and after the removal of smoking areas in restaurants," in 2004.
If this is the case, then how can the article possibly conclude that the smoking ban (which was implemented in 2004) led to a decline in the rate of acute coronary syndrome admissions?
The answer is: it can't. That it draws this conclusion anyway is essentially a sleight of hand. It is scientifically faulty at best and disingenuous at worst.
Not unexpectedly, for being willing to criticize anti-smoking research on scientific grounds, I was accused (in the comments section) of being a paid tobacco industry lobbyist. Well then, I guess I'll be excitedly anticipating the receipt of my next paycheck.
Monday, July 18, 2011
35% of Nurses Will Not Be Eligible to Work for Auckland Health Board Under New Smoker Discrimination Policy
Under a new smoker discrimination policy being implemented by the Auckland District Health Board, 35% of current nurses will no longer be eligible to work for the Health Board. The policy precludes smokers from being employed as new hires.
According to the article: "A nurses' union is accusing Auckland's District Health Board of discrimination for considering not hiring smokers. The board, which employs more than 10,000 people, has instructed a proposal be drawn up that would see prospective health workers who smoke turned away. ADHB Executive Director of Nursing Taima Campbell, who proposed the original idea, said health workers had a responsibility to be positive role models. ... The Nurses Organisation says 35% of its members smoke, and it will oppose the policy."
A Health Board member defended the decision, arguing that: "We need our staff to be good role models and not smoke themselves."
The nurses union is opposing the policy. More than one in three nurses in Auckland are smokers.
The Rest of the Story
Unlike here in the U.S., nurses in New Zealand are standing up for their employment rights. The nurses union is rightly noting that the proposed policy represents employment discrimination and that it goes against everything they believe about equal opportunity.
In addition, the union made it clear that the policy will result in less qualified nurses being hired, since the smoking rate among nurses is 35%. You can't eliminate one-third of potential employees arbitrarily and expect to end up with the most highly qualified work force. In fact, you will not have the most highly qualified work force. You will be sacrificing nursing quality and ultimately, patient care.
The Health Board seems to believe that nurses must be good role models. So are they also refusing to hire obese or overweight nurses? Are they refusing to hire nurses who don't wear seat belts? Are they taking a careful sexual history of prospective employees to make sure that their nurses set a good example in that regard? Are they inquiring about marital fidelity? Surely, if you are going to be a good role model for others, you wouldn't want to have someone who is cheating on his or her spouse. Are they also inquiring about speeding tickets, failure to pay taxes, history of misdemeanor offenses, and eating habits?
According to the article: "A nurses' union is accusing Auckland's District Health Board of discrimination for considering not hiring smokers. The board, which employs more than 10,000 people, has instructed a proposal be drawn up that would see prospective health workers who smoke turned away. ADHB Executive Director of Nursing Taima Campbell, who proposed the original idea, said health workers had a responsibility to be positive role models. ... The Nurses Organisation says 35% of its members smoke, and it will oppose the policy."
A Health Board member defended the decision, arguing that: "We need our staff to be good role models and not smoke themselves."
The nurses union is opposing the policy. More than one in three nurses in Auckland are smokers.
The Rest of the Story
Unlike here in the U.S., nurses in New Zealand are standing up for their employment rights. The nurses union is rightly noting that the proposed policy represents employment discrimination and that it goes against everything they believe about equal opportunity.
In addition, the union made it clear that the policy will result in less qualified nurses being hired, since the smoking rate among nurses is 35%. You can't eliminate one-third of potential employees arbitrarily and expect to end up with the most highly qualified work force. In fact, you will not have the most highly qualified work force. You will be sacrificing nursing quality and ultimately, patient care.
The Health Board seems to believe that nurses must be good role models. So are they also refusing to hire obese or overweight nurses? Are they refusing to hire nurses who don't wear seat belts? Are they taking a careful sexual history of prospective employees to make sure that their nurses set a good example in that regard? Are they inquiring about marital fidelity? Surely, if you are going to be a good role model for others, you wouldn't want to have someone who is cheating on his or her spouse. Are they also inquiring about speeding tickets, failure to pay taxes, history of misdemeanor offenses, and eating habits?
Friday, July 15, 2011
FDA to Waste $2.1 Million on Strategy Proven to Be Ineffective in Deterring Youth Smoking
According to an article on the WABI-TV web site, the FDA is awarding a $2.1 million grant to the state of Maine to help enforce laws to prevent the sale of tobacco to minors.
Dr. Lawrence Deyton, Director of the FDA's Center for Tobacco Products, says Maine has been awarded a contract that could be worth as much as $2.1 million dollars. The money is to help enforce FDA tobacco product laws and regulations. ... "This additional money into the state to help with our inspections of retailers to ensure that there aren't any underage sales of tobacco to minors is a huge step in the right direction for Maine." The contract also provides the state with new resources as well as the authority to inspect retailers and collect evidence needed to take action when the law is broken. ... "It's the retailers who are on the front lines and who can truly be the decisive factor in helping to protect kids from starting to use tobacco," Dr. Deyton told the crowd in Augusta."
The Rest of the Story
This is a waste of money. Enforcement of youth access laws has been demonstrated to be an ineffective strategy to prevent youth smoking. A meta-analysis of multiple studies of youth access laws found no relationship between the reported compliance rates and the prevalence of youth smoking. The article concluded that: "Given the limited resources available for tobacco control, as well as the expense of conducting youth access programs, tobacco control advocates should abandon this strategy and devote the limited resources that are available for tobacco control toward other interventions with proven effectiveness."
It is unfortunate that the FDA Center for Tobacco Products is embracing this ineffective strategy, rather than evidence-based practices which have been proven effective in reducing youth smoking.
One reason why youth access laws do not work is that cigarette purchase is just one of many sources of cigarettes for youth smokers. In fact, research has shown that only about half of youth smokers purchase their own cigarettes in stores. Thus, even if all sale of tobacco to youths were halted, it would not necessarily prevent youths from being able to obtain cigarettes.
Moreover, compliance checks are a poor indication of actual sale of tobacco to minors. The youths used in these checks are often nonsmokers and it is easy for clerks to recognize that these are not legitimate purchase attempts. Furthermore, the youths are instructed to tell the truth, something they don't need to do in "real life." Thus, even when very high compliance rates can be achieved, this does not necessarily mean that it is difficult for youth to buy or obtain cigarettes.
That youth access laws are so ineffective is evidenced by the fact that the tobacco companies have long supported this approach. They realized long ago that youth access restrictions offer very little obstacle to cigarette smoking by youth.
Hopefully, the FDA will not waste millions of dollars like this in other states as well.
Dr. Lawrence Deyton, Director of the FDA's Center for Tobacco Products, says Maine has been awarded a contract that could be worth as much as $2.1 million dollars. The money is to help enforce FDA tobacco product laws and regulations. ... "This additional money into the state to help with our inspections of retailers to ensure that there aren't any underage sales of tobacco to minors is a huge step in the right direction for Maine." The contract also provides the state with new resources as well as the authority to inspect retailers and collect evidence needed to take action when the law is broken. ... "It's the retailers who are on the front lines and who can truly be the decisive factor in helping to protect kids from starting to use tobacco," Dr. Deyton told the crowd in Augusta."
The Rest of the Story
This is a waste of money. Enforcement of youth access laws has been demonstrated to be an ineffective strategy to prevent youth smoking. A meta-analysis of multiple studies of youth access laws found no relationship between the reported compliance rates and the prevalence of youth smoking. The article concluded that: "Given the limited resources available for tobacco control, as well as the expense of conducting youth access programs, tobacco control advocates should abandon this strategy and devote the limited resources that are available for tobacco control toward other interventions with proven effectiveness."
It is unfortunate that the FDA Center for Tobacco Products is embracing this ineffective strategy, rather than evidence-based practices which have been proven effective in reducing youth smoking.
One reason why youth access laws do not work is that cigarette purchase is just one of many sources of cigarettes for youth smokers. In fact, research has shown that only about half of youth smokers purchase their own cigarettes in stores. Thus, even if all sale of tobacco to youths were halted, it would not necessarily prevent youths from being able to obtain cigarettes.
Moreover, compliance checks are a poor indication of actual sale of tobacco to minors. The youths used in these checks are often nonsmokers and it is easy for clerks to recognize that these are not legitimate purchase attempts. Furthermore, the youths are instructed to tell the truth, something they don't need to do in "real life." Thus, even when very high compliance rates can be achieved, this does not necessarily mean that it is difficult for youth to buy or obtain cigarettes.
That youth access laws are so ineffective is evidenced by the fact that the tobacco companies have long supported this approach. They realized long ago that youth access restrictions offer very little obstacle to cigarette smoking by youth.
Hopefully, the FDA will not waste millions of dollars like this in other states as well.
Wednesday, July 13, 2011
More New Research Suggests that Graphic Cigarette Warning Labels Will Not Be Effective in Deterring Smokers
More research, this time published in the journal Human Brain Mapping, suggests that graphic warning labels on cigarette packs will be far less effective in deterring smokers than is being touted by anti-smoking groups and politicians. An article published online ahead of print reports that smokers who are addicted to cigarettes and are deprived of being able to smoke for a short time are unresponsive to fear warnings about the health effects of smoking.
(see: Onur, O. A., Patin, A., Mihov, Y., Buecher, B., Stoffel-Wagner, B., Schlaepfer, T. E., Walter, H., Maier, W. and Hurlemann, R. (2011), Overnight deprivation from smoking disrupts amygdala responses to fear. Human Brain Mapping. doi: 10.1002/hbm.21293).
According to a Bloomberg News summary of the article: "Images of corpses and cancerous lungs on cigarette packs may do little to deter nicotine addicts, judging from new research on how smokers’ brains work. The brain’s fear center becomes desensitized in heavy smokers who haven’t been allowed to light up for 12 hours, a team of doctors in Germany found in a study published today. ... “In those who stop smoking, the activity of the fear center has been lowered so much that they are not very receptive to the scary photos,” Rene Hurlemann, a doctor at the Bonn University Clinic in Germany and one of the study’s authors, said in a statement. Hurlemann and his colleagues recruited 28 young volunteers who consumed an average of 17 cigarettes a day and had used tobacco for nine years, and the same number of non-smokers. The groups were shown images of happy, neutral and fearful faces while researchers recorded their brain activity. They responded in similar ways until the organizers deprived the smokers of tobacco. After just a few hours of deprivation, the smokers’ brains were less responsive to fearful faces, the researchers found."
The Rest of the Story
This research adds to a body of psychology and neurophysiology research which suggests that graphic warning labels on cigarette packages will have very little effect in deterring smoking among existing smokers who are addicted to cigarettes.
The findings of this study are in line with the opinion that I expressed in a Bloomberg news story about cigarette warning labels, which is featured on the same page as the story about this study: "Michael Siegel, an associate professor at the Boston University School of Public Health, talks about new U.S. government requirements for cigarette warning labels. Images of a corpse and cancerous lungs are among nine graphic warnings that tobacco companies must start placing on cigarette packs sold in the U.S. next year. Siegel speaks with Carol Massar and Matt Miller on Bloomberg Television's 'Street Smart.'"
(see: Onur, O. A., Patin, A., Mihov, Y., Buecher, B., Stoffel-Wagner, B., Schlaepfer, T. E., Walter, H., Maier, W. and Hurlemann, R. (2011), Overnight deprivation from smoking disrupts amygdala responses to fear. Human Brain Mapping. doi: 10.1002/hbm.21293).
According to a Bloomberg News summary of the article: "Images of corpses and cancerous lungs on cigarette packs may do little to deter nicotine addicts, judging from new research on how smokers’ brains work. The brain’s fear center becomes desensitized in heavy smokers who haven’t been allowed to light up for 12 hours, a team of doctors in Germany found in a study published today. ... “In those who stop smoking, the activity of the fear center has been lowered so much that they are not very receptive to the scary photos,” Rene Hurlemann, a doctor at the Bonn University Clinic in Germany and one of the study’s authors, said in a statement. Hurlemann and his colleagues recruited 28 young volunteers who consumed an average of 17 cigarettes a day and had used tobacco for nine years, and the same number of non-smokers. The groups were shown images of happy, neutral and fearful faces while researchers recorded their brain activity. They responded in similar ways until the organizers deprived the smokers of tobacco. After just a few hours of deprivation, the smokers’ brains were less responsive to fearful faces, the researchers found."
The Rest of the Story
This research adds to a body of psychology and neurophysiology research which suggests that graphic warning labels on cigarette packages will have very little effect in deterring smoking among existing smokers who are addicted to cigarettes.
The findings of this study are in line with the opinion that I expressed in a Bloomberg news story about cigarette warning labels, which is featured on the same page as the story about this study: "Michael Siegel, an associate professor at the Boston University School of Public Health, talks about new U.S. government requirements for cigarette warning labels. Images of a corpse and cancerous lungs are among nine graphic warnings that tobacco companies must start placing on cigarette packs sold in the U.S. next year. Siegel speaks with Carol Massar and Matt Miller on Bloomberg Television's 'Street Smart.'"
Monday, July 11, 2011
Research Firm Report Estimates that Graphic Warning Labels Will Reduce Cigarette Consumption by No More than 1%
A report by the research firm IBISWorld estimates that the graphic warning labels to be placed on cigarettes staring next year will reduce cigarette consumption by no more than 1%, according to an Associated Press article.
According to the article: "The nation's top tobacco companies' sales aren't expected to go up in smoke despite new grisly warning labels that are set to appear on U.S. cigarettes packs next year. The graphic labels, which were released in June by the Food and Drug Administration and include an image of rotting teeth and gums, will cause a decline of less than one percent in overall U.S. tobacco revenues in 2013, according to a recent analysis by research firm IBISWorld. An average person smokes fifteen cigarettes a day at a cost of about $1,500 per year, which translates to about $300 million in lost revenue. That's only a fraction of the estimated $43.8 billion in revenue for the tobacco industry in 2013, the firm's calculation show."
The IBISWorld analyst predicted that "in the near term, it won't have much of an impact."
The Rest of the Story
This analysis comports with my own evaluation of the likely impact of the warning labels, which I opined last week would be minimal. However, politicians (like Senator Lautenberg) and anti-smoking organizations (like the Campaign for Tobacco-Free Kids and World Health Organization) have been boasting about how much of an impact these warning labels will have.
Sadly, the warning labels are the strongest aspect, and only real public health benefit of the FDA Tobacco Act. There is nothing else in the legislation which will have any substantial positive public health impact. And the positive effect of the warning labels is estimated to be quite minimal.
The one substantial effect which these warning labels will have, however, is to completely immunize the tobacco industry against litigation. No jury is going to find the tobacco companies responsible, or even partly responsible, for damage caused by their products when these companies can argue that consumers are adequately warned of the product's dangers by virtue of these large warning labels.
I believe that for the industry, the benefits of virtual immunity against future litigation will outweigh the one percent or so decline in cigarette sales.
The FDA Tobacco Act remains, in my opinion, one of the worst deals ever agreed to by a public health organization.
According to the article: "The nation's top tobacco companies' sales aren't expected to go up in smoke despite new grisly warning labels that are set to appear on U.S. cigarettes packs next year. The graphic labels, which were released in June by the Food and Drug Administration and include an image of rotting teeth and gums, will cause a decline of less than one percent in overall U.S. tobacco revenues in 2013, according to a recent analysis by research firm IBISWorld. An average person smokes fifteen cigarettes a day at a cost of about $1,500 per year, which translates to about $300 million in lost revenue. That's only a fraction of the estimated $43.8 billion in revenue for the tobacco industry in 2013, the firm's calculation show."
The IBISWorld analyst predicted that "in the near term, it won't have much of an impact."
The Rest of the Story
This analysis comports with my own evaluation of the likely impact of the warning labels, which I opined last week would be minimal. However, politicians (like Senator Lautenberg) and anti-smoking organizations (like the Campaign for Tobacco-Free Kids and World Health Organization) have been boasting about how much of an impact these warning labels will have.
Sadly, the warning labels are the strongest aspect, and only real public health benefit of the FDA Tobacco Act. There is nothing else in the legislation which will have any substantial positive public health impact. And the positive effect of the warning labels is estimated to be quite minimal.
The one substantial effect which these warning labels will have, however, is to completely immunize the tobacco industry against litigation. No jury is going to find the tobacco companies responsible, or even partly responsible, for damage caused by their products when these companies can argue that consumers are adequately warned of the product's dangers by virtue of these large warning labels.
I believe that for the industry, the benefits of virtual immunity against future litigation will outweigh the one percent or so decline in cigarette sales.
The FDA Tobacco Act remains, in my opinion, one of the worst deals ever agreed to by a public health organization.
Thursday, July 07, 2011
New Published Study Finds No Evidence of a Decline in Heart Attacks Following Implementation of a Strong Worksite and Restaurant Smoking Ban
A new study published in the current issue of Preventing Chronic Disease: Public Health Research, Practice, and Policy finds no evidence of any significant decline in acute coronary syndrome (heart attacks and unstable angina) after implementation of a strong workplace and restaurant smoking ban in Kanawha County in 2004.
(see: Rahul Gupta, MD, MPH; Juhua Luo, PhD; Robert H. Anderson, MA; Anita Ray, RS. Clean Indoor Air Regulation and Incidence of Hospital Admissions for Acute Coronary Syndrome in Kanawha County, West Virginia. Preventing Chronic Disease: Public Health Research, Practice, and Policy 2011. 8(4):A77.)
Kanawha County (West Virginia) had virtually no clean indoor air protection in place until January 1, 2004. Prior to that time, smoking was allowed in most workplaces and in up to 50% of designated seating in restaurants. As of January 1, 2004, smoking was prohibited entirely in workplaces, including restaurants.The investigators examined hospital admission rates for acute coronary syndrome from 2000 through 2008, thus including four years prior to the smoking ban and four years following the smoking ban. Had the smoking ban led to a decline in acute coronary syndrome admissions, one would have seen such a decline during the 2004-2008 period compared to the 2000-2004 period.
The data, however, show no such decline. Instead, the data show a steady decline in acute coronary syndrome (ACS) rates that is consistent throughout the study period and does not accelerate after the implementation of the smoking ban.
Here are the actual figures:
Prior to the smoking ban (2000-2004): Age-adjusted rate of ACS hospital admissions declined by 20.3%, or 4.1% per year.
After the smoking ban (2004-2008): Age-adjusted rate of ACS hospital admissions declined by 21.2%, or by 4.2% per year.
Thus, there was no change in the trend in ACS admissions after implementation of the strong smoking ban.
The authors acknowledge this finding: "We did not find additional significant change between, before, and after the removal of smoking areas in restaurants (the key change in the CIAR revision that took effect January 1, 2004) after accounting for the sustainable decline of ACS hospitalizations since the 2000 regulation revision (Table 1)."
They quantify the change in ACS admission rates associated with the smoking ban. The relative risk of ACS admission associated with the smoking ban was 1.02 (95% confidence interval, 0.92 to 1.12). Since the confidence interval crosses 1.0, this means that there was no significant effect of the smoking ban on ACS admission rates.
In summary, this study demonstrates that a stringent smoking ban implemented in Kanawha County was not associated with any significant change in hospital admissions for acute coronary events, refuting the conclusions of other studies which reported such effects.
The Rest of the Story
Miraculously, this is not what the study authors chose to report in their conclusions. As if pulling a silver lining out of a dark cloud, the investigators instead conclude as follows: "In the presence of a CIAR [clean indoor air regulation], a consistent decline in incidence of hospital admissions for ACS can be demonstrated."
The same conclusion is reiterated later in the paper: "In conclusion, our results demonstrate that from 2000 through 2008, the rate of hospital admissions for ACS has consistently declined in Kanawha County in the presence of an existing CIAR."
This is an incredibly disingenuous sleight of hand.
The analysis tested a specific hypothesis: Was the smoking ban (implemented on January 1, 2004) associated with a significant decline in ACS hospital admissions). The analysis included a specific regression coefficient to test for this effect. The coefficient was close to zero and was not statistically significant, indicating that the smoking ban had no effect on ACS hospital admissions.
But instead of simply concluding that they failed to find any significant effect of the smoking ban on acute coronary event admission rates, the authors chose to spin the paper as having found that in the presence of a clean indoor air regulation of some kind (yes, a very weak ordinance was in effect as early as 1995), the rate of ACS hospital admissions dropped consistently over time.
Well of course the ACS hospital admissions dropped during the study period! These rates are declining everywhere. Cardiovascular disease admission rates have dropped everywhere during the past decade. There are major secular changes taking place in coronary artery disease medical management and treatment, including the availability of cholesterol-lowering statin drugs, better control of hypertension, and improved surgical treatments such as angioplasty.
That coronary syndrome rates dropped in Kanawha County during the period 2000-2008 is a non-finding. I could have told you that without even looking at the data. It would have been absolutely striking to have found an increase in ACS admission rates during this time period.
To associate the decline in ACS admission rates during this time period with the almost non-existent smoking restrictions is ludicrous. First of all, the paper does not show any change in the admission rate from before to after the weak county regulations. They had in fact been in effect since 1995. So unless the paper went back to about 1990, it could not possibly draw conclusions about the relationship between the county regulation passed in 1995 and any change in ACS admission rates.
Furthermore, the so-called clean indoor air regulation in the county is meaningless. Restaurants were allowed to designate up to 50% of their seating for smoking. That isn't a smoking ban. It's essentially no regulation. In almost every other study of this kind, such a regulation would be considered the absence of a smoking ban. Obviously, a 50% designated smoking area policy is not going to protect customers from secondhand smoke exposure. This has been proven in multiple studies.
So this paper has pulled two sleight of hand tricks to make it look like a positive finding when in fact the main finding is a negative one. It's incredibly impressive to me to see this kind of manipulation take place in what is a very simple and straightforward study that fails to find any effect of a strong smoking ban on acute coronary event hospitalization rates.
I think it shows just how seriously the quality of tobacco control science has degraded.
A question: How many anti-smoking groups do you think are going to disseminate the findings of this study? I am so sure that not a single group will share these results with the public that I'm willing to bet $100 that no group [Missouri GASP is not eligible] which previously reported the results of a study showing a positive effect of a smoking ban in reducing ACS admissions will now report the result of this study which clearly shows no effect of a smoking ban in reducing ACS admissions.
If any group does report this negative finding, I'll donate my $100 prize offering to that organization. Believe me, I'm not rushing off to find my checkbook. This is a bet that is a sure thing. No anti-smoking group will report this finding because anti-smoking groups aren't interested in the truth. They are interested in results that are favorable to their cause.
This is the sad lesson that I have learned over the past few years. It is disillusioning to me and to my vision of the importance of scientific integrity in the practice of tobacco control in public health.
(see: Rahul Gupta, MD, MPH; Juhua Luo, PhD; Robert H. Anderson, MA; Anita Ray, RS. Clean Indoor Air Regulation and Incidence of Hospital Admissions for Acute Coronary Syndrome in Kanawha County, West Virginia. Preventing Chronic Disease: Public Health Research, Practice, and Policy 2011. 8(4):A77.)
Kanawha County (West Virginia) had virtually no clean indoor air protection in place until January 1, 2004. Prior to that time, smoking was allowed in most workplaces and in up to 50% of designated seating in restaurants. As of January 1, 2004, smoking was prohibited entirely in workplaces, including restaurants.The investigators examined hospital admission rates for acute coronary syndrome from 2000 through 2008, thus including four years prior to the smoking ban and four years following the smoking ban. Had the smoking ban led to a decline in acute coronary syndrome admissions, one would have seen such a decline during the 2004-2008 period compared to the 2000-2004 period.
The data, however, show no such decline. Instead, the data show a steady decline in acute coronary syndrome (ACS) rates that is consistent throughout the study period and does not accelerate after the implementation of the smoking ban.
Here are the actual figures:
Prior to the smoking ban (2000-2004): Age-adjusted rate of ACS hospital admissions declined by 20.3%, or 4.1% per year.
After the smoking ban (2004-2008): Age-adjusted rate of ACS hospital admissions declined by 21.2%, or by 4.2% per year.
Thus, there was no change in the trend in ACS admissions after implementation of the strong smoking ban.
The authors acknowledge this finding: "We did not find additional significant change between, before, and after the removal of smoking areas in restaurants (the key change in the CIAR revision that took effect January 1, 2004) after accounting for the sustainable decline of ACS hospitalizations since the 2000 regulation revision (Table 1)."
They quantify the change in ACS admission rates associated with the smoking ban. The relative risk of ACS admission associated with the smoking ban was 1.02 (95% confidence interval, 0.92 to 1.12). Since the confidence interval crosses 1.0, this means that there was no significant effect of the smoking ban on ACS admission rates.
In summary, this study demonstrates that a stringent smoking ban implemented in Kanawha County was not associated with any significant change in hospital admissions for acute coronary events, refuting the conclusions of other studies which reported such effects.
The Rest of the Story
Miraculously, this is not what the study authors chose to report in their conclusions. As if pulling a silver lining out of a dark cloud, the investigators instead conclude as follows: "In the presence of a CIAR [clean indoor air regulation], a consistent decline in incidence of hospital admissions for ACS can be demonstrated."
The same conclusion is reiterated later in the paper: "In conclusion, our results demonstrate that from 2000 through 2008, the rate of hospital admissions for ACS has consistently declined in Kanawha County in the presence of an existing CIAR."
This is an incredibly disingenuous sleight of hand.
The analysis tested a specific hypothesis: Was the smoking ban (implemented on January 1, 2004) associated with a significant decline in ACS hospital admissions). The analysis included a specific regression coefficient to test for this effect. The coefficient was close to zero and was not statistically significant, indicating that the smoking ban had no effect on ACS hospital admissions.
But instead of simply concluding that they failed to find any significant effect of the smoking ban on acute coronary event admission rates, the authors chose to spin the paper as having found that in the presence of a clean indoor air regulation of some kind (yes, a very weak ordinance was in effect as early as 1995), the rate of ACS hospital admissions dropped consistently over time.
Well of course the ACS hospital admissions dropped during the study period! These rates are declining everywhere. Cardiovascular disease admission rates have dropped everywhere during the past decade. There are major secular changes taking place in coronary artery disease medical management and treatment, including the availability of cholesterol-lowering statin drugs, better control of hypertension, and improved surgical treatments such as angioplasty.
That coronary syndrome rates dropped in Kanawha County during the period 2000-2008 is a non-finding. I could have told you that without even looking at the data. It would have been absolutely striking to have found an increase in ACS admission rates during this time period.
To associate the decline in ACS admission rates during this time period with the almost non-existent smoking restrictions is ludicrous. First of all, the paper does not show any change in the admission rate from before to after the weak county regulations. They had in fact been in effect since 1995. So unless the paper went back to about 1990, it could not possibly draw conclusions about the relationship between the county regulation passed in 1995 and any change in ACS admission rates.
Furthermore, the so-called clean indoor air regulation in the county is meaningless. Restaurants were allowed to designate up to 50% of their seating for smoking. That isn't a smoking ban. It's essentially no regulation. In almost every other study of this kind, such a regulation would be considered the absence of a smoking ban. Obviously, a 50% designated smoking area policy is not going to protect customers from secondhand smoke exposure. This has been proven in multiple studies.
So this paper has pulled two sleight of hand tricks to make it look like a positive finding when in fact the main finding is a negative one. It's incredibly impressive to me to see this kind of manipulation take place in what is a very simple and straightforward study that fails to find any effect of a strong smoking ban on acute coronary event hospitalization rates.
I think it shows just how seriously the quality of tobacco control science has degraded.
A question: How many anti-smoking groups do you think are going to disseminate the findings of this study? I am so sure that not a single group will share these results with the public that I'm willing to bet $100 that no group [Missouri GASP is not eligible] which previously reported the results of a study showing a positive effect of a smoking ban in reducing ACS admissions will now report the result of this study which clearly shows no effect of a smoking ban in reducing ACS admissions.
If any group does report this negative finding, I'll donate my $100 prize offering to that organization. Believe me, I'm not rushing off to find my checkbook. This is a bet that is a sure thing. No anti-smoking group will report this finding because anti-smoking groups aren't interested in the truth. They are interested in results that are favorable to their cause.
This is the sad lesson that I have learned over the past few years. It is disillusioning to me and to my vision of the importance of scientific integrity in the practice of tobacco control in public health.
Wednesday, July 06, 2011
Senator Lautenberg's Self-Congratulatory Pat on the Back About Cigarette Warning Labels Shows Lack of Understanding of the Nature of Smoking Addiction
In a press release issued last week, Senator Frank Lautenberg (D-NJ) congratulated himself for the introduction of nine rotating graphic warning labels on cigarette packs, to be unveiled in March 2012, which resulted from the legislation he supported in 2009.
Senator Lautenberg boasted as follows: "For decades, Big Tobacco got away with slick marketing campaigns that fooled the public into thinking smoking was glamorous – and now we’re turning the tables on them. Each time a smoker reaches for a pack of cigarettes, the deadly truth will be staring them in the face. I applaud the FDA for breathing new life into our country’s efforts to alert the public to the lethal consequences of tobacco addiction. I've been working for over a decade to make these warning labels a reality, and I believe the FDA has taken a crucial step to make people – especially teenagers – think twice before lighting up."
The Rest of the Story
The key lack of insight in Senator Lautenberg's statement is highlighted in bold above: these graphic warning labels will confront smokers each time he or she reaches for a pack of cigarettes. In other words, it is too late. The smoker is already addicted to smoking. He or she has already made the decision to smoke. He or she has already purchased the cigarettes. He or she already has a craving to smoke, and is likely acting due to his or her cigarette addiction. Yet Lautenberg (and a number of anti-smoking groups) appear to believe that a large number of smokers are going to overcome their addiction to smoking simply by being reminded that cigarette smoking is harmful to their health.
This mentality has pervaded the tobacco control movement for too long. It just doesn't work. In 2011, people are not smoking because of lack of awareness that cigarettes are dangerous and could kill them. They are smoking despite that knowledge and awareness. That's the power of the addiction.
Unless and until Congress and anti-smoking groups discard the old dogma of the Health Belief Model (i.e., smokers will quit if only they are informed about the devastating health effects) and adopt a new model that is based on the recognition that smoking is a powerful addiction that does not respond to rational messages and rational decision-making, we will continue to make no more than marginal progress in the effort to promote smoking cessation and substantially reduce smoking rates and their associated morbidity and mortality.
I see a lot of self-congratulations going on among tobacco control groups and policy makers, but I see very little legislation or policy with teeth that will actually make a serious difference in smoking rates and therefore smoking-related morbidity and mortality. In fact, the present emphasis on ingredient disclosure and regulation, warning labels, youth access restrictions, and obstruction of safer competitive products are all working effectively to obscure the real solutions. This is exactly the way Philip Morris planned it. I stand in awe of their work, as the health groups and politicians fell for the trap hook, line, and sinker.
Senator Lautenberg boasted as follows: "For decades, Big Tobacco got away with slick marketing campaigns that fooled the public into thinking smoking was glamorous – and now we’re turning the tables on them. Each time a smoker reaches for a pack of cigarettes, the deadly truth will be staring them in the face. I applaud the FDA for breathing new life into our country’s efforts to alert the public to the lethal consequences of tobacco addiction. I've been working for over a decade to make these warning labels a reality, and I believe the FDA has taken a crucial step to make people – especially teenagers – think twice before lighting up."
The Rest of the Story
The key lack of insight in Senator Lautenberg's statement is highlighted in bold above: these graphic warning labels will confront smokers each time he or she reaches for a pack of cigarettes. In other words, it is too late. The smoker is already addicted to smoking. He or she has already made the decision to smoke. He or she has already purchased the cigarettes. He or she already has a craving to smoke, and is likely acting due to his or her cigarette addiction. Yet Lautenberg (and a number of anti-smoking groups) appear to believe that a large number of smokers are going to overcome their addiction to smoking simply by being reminded that cigarette smoking is harmful to their health.
This mentality has pervaded the tobacco control movement for too long. It just doesn't work. In 2011, people are not smoking because of lack of awareness that cigarettes are dangerous and could kill them. They are smoking despite that knowledge and awareness. That's the power of the addiction.
Unless and until Congress and anti-smoking groups discard the old dogma of the Health Belief Model (i.e., smokers will quit if only they are informed about the devastating health effects) and adopt a new model that is based on the recognition that smoking is a powerful addiction that does not respond to rational messages and rational decision-making, we will continue to make no more than marginal progress in the effort to promote smoking cessation and substantially reduce smoking rates and their associated morbidity and mortality.
I see a lot of self-congratulations going on among tobacco control groups and policy makers, but I see very little legislation or policy with teeth that will actually make a serious difference in smoking rates and therefore smoking-related morbidity and mortality. In fact, the present emphasis on ingredient disclosure and regulation, warning labels, youth access restrictions, and obstruction of safer competitive products are all working effectively to obscure the real solutions. This is exactly the way Philip Morris planned it. I stand in awe of their work, as the health groups and politicians fell for the trap hook, line, and sinker.
Tuesday, July 05, 2011
Meta-Analysis: Chantix Causes One Heart Attack for Every Three Patients It Helps Quit Smoking; Anti-Smoking Groups: Keep Chantix, Ban E-Cigs
A new meta-analysis published yesterday in the Canadian Medical Association Journal reports that the smoking cessation drug Chantix is associated with a 70% increase in serious adverse cardiovascular events, such as heart attacks, compared to placebo (see: Singh S, Loke YK, Spangler JG, Furberg CD. Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. Canadian Medical Association Journal 2011. DOI:10.1503/cmaj.110218).
The meta-analysis "analyzed data from 14 doubleblind randomized controlled trials involving 8216 participants. The trials ranged in duration from 7 to 52 weeks." The major finding was that "Varenicline was associated with a significantly increased risk of serious adverse cardiovascular events compared with placebo (1.06% [52/4908] in varenicline group v. 0.82% [27/3308] in placebo group; Peto odds ratio [OR] 1.72, 95% confidence interval [CI] 1.09–2.71."
The authors further estimated the effects of treating a population with Chantix in terms of the number of adverse cardiovascular events that would occur compared to the number of smokers who would quit smoking because of the use of Chantix. The results were as follows:
"Varenicline increases the chances of a successful quit attempt by twofold compared with unassisted smoking cessation. However, at the population level, most smokers quit unassisted. The number needed to treat with varenicline for one additional person to successfully quit smoking is estimated to be 10 (95% CI 8–13). Assuming a baseline risk of serious adverse cardiovascular events of 5.57% per year (among smokers with stable cardiovascular disease), the number needed to harm (the number needed to cause one additional serious cardiovascular event) with varenicline is estimated to be 28 (95% CI 13 to 213) per year. The risk of additional serious adverse events associated with varenicline use includes the potential for serious neuropsychiatric symptoms such as depressed mood, agitation and suicidal thoughts."
Thus, for every 30 patients treated with Chantix, this article predicts that three people will quit smoking successfully due to the Chantix but that one person will have a serious cardiovascular event like a heart attack. In addition, an unknown number may experience severe neuropsychiatric effects such as suicidal ideation.
Given these tradeoffs, as well as the fact that there are other smoking cessation medications available and the overall long-term success rate with Chantix is dismal, it hardly seems justified to recommend that Chantix remain a mainstay of a national smoking cessation strategy on a population level.
The Rest of the Story
The public health impact of these findings is substantial. According to one of the study authors, as quoted in MedPage Today: "'In absolute terms, it is a small difference,' first author Sonal Singh, MD, of Johns Hopkins, told MedPage Today. 'However, when you consider the difference from a population perspective, you get a very different picture. It is estimated that 7 million people in the U.S. were using Chantix last year. If you apply our results to the total number of users, I estimate that there were 62,500 cardiac events that were linked to use of Chantix. That is not a small number, by any standards.'"
So in addition to the more than 200 suicides that have been linked to Chantix, Singh is now estimating that Chantix causes 62,500 serious cardiac events (e.g., heart attacks) per year. This is all in the name of helping one person quit smoking out of every 30 who are treated. While I suppose it is possible that the benefits of Chantix still outweigh the risks, it is difficult for me to see how, given these numbers. It is clear that in the short-term, the benefits of reducing cardiac risk due to quitting smoking is overshadowed by the increased risk of severe adverse cardiovascular events.
In contrast to the 62,500 serious cardiac events attributable to Chantix each year, the use of electronic cigarettes to quit smoking has been associated with zero serious adverse events.
Nevertheless, the official policy recommendation of each of the following anti-smoking organizations is that Chantix should remain on the market while electronic cigarettes should be taken off the market until proven "safe and effective":
The meta-analysis "analyzed data from 14 doubleblind randomized controlled trials involving 8216 participants. The trials ranged in duration from 7 to 52 weeks." The major finding was that "Varenicline was associated with a significantly increased risk of serious adverse cardiovascular events compared with placebo (1.06% [52/4908] in varenicline group v. 0.82% [27/3308] in placebo group; Peto odds ratio [OR] 1.72, 95% confidence interval [CI] 1.09–2.71."
The authors further estimated the effects of treating a population with Chantix in terms of the number of adverse cardiovascular events that would occur compared to the number of smokers who would quit smoking because of the use of Chantix. The results were as follows:
"Varenicline increases the chances of a successful quit attempt by twofold compared with unassisted smoking cessation. However, at the population level, most smokers quit unassisted. The number needed to treat with varenicline for one additional person to successfully quit smoking is estimated to be 10 (95% CI 8–13). Assuming a baseline risk of serious adverse cardiovascular events of 5.57% per year (among smokers with stable cardiovascular disease), the number needed to harm (the number needed to cause one additional serious cardiovascular event) with varenicline is estimated to be 28 (95% CI 13 to 213) per year. The risk of additional serious adverse events associated with varenicline use includes the potential for serious neuropsychiatric symptoms such as depressed mood, agitation and suicidal thoughts."
Thus, for every 30 patients treated with Chantix, this article predicts that three people will quit smoking successfully due to the Chantix but that one person will have a serious cardiovascular event like a heart attack. In addition, an unknown number may experience severe neuropsychiatric effects such as suicidal ideation.
Given these tradeoffs, as well as the fact that there are other smoking cessation medications available and the overall long-term success rate with Chantix is dismal, it hardly seems justified to recommend that Chantix remain a mainstay of a national smoking cessation strategy on a population level.
The Rest of the Story
The public health impact of these findings is substantial. According to one of the study authors, as quoted in MedPage Today: "'In absolute terms, it is a small difference,' first author Sonal Singh, MD, of Johns Hopkins, told MedPage Today. 'However, when you consider the difference from a population perspective, you get a very different picture. It is estimated that 7 million people in the U.S. were using Chantix last year. If you apply our results to the total number of users, I estimate that there were 62,500 cardiac events that were linked to use of Chantix. That is not a small number, by any standards.'"
So in addition to the more than 200 suicides that have been linked to Chantix, Singh is now estimating that Chantix causes 62,500 serious cardiac events (e.g., heart attacks) per year. This is all in the name of helping one person quit smoking out of every 30 who are treated. While I suppose it is possible that the benefits of Chantix still outweigh the risks, it is difficult for me to see how, given these numbers. It is clear that in the short-term, the benefits of reducing cardiac risk due to quitting smoking is overshadowed by the increased risk of severe adverse cardiovascular events.
In contrast to the 62,500 serious cardiac events attributable to Chantix each year, the use of electronic cigarettes to quit smoking has been associated with zero serious adverse events.
Nevertheless, the official policy recommendation of each of the following anti-smoking organizations is that Chantix should remain on the market while electronic cigarettes should be taken off the market until proven "safe and effective":
- The Campaign for Tobacco-Free Kids;
- The American Cancer Society;
- The American Heart Association;
- The American Lung Association;
- Action on Smoking and Health;
- The American Academy of Pediatrics; and
- The American Legacy Foundation.
- All have or have had financial associations with Pfizer, the manufacturer of Chantix.
Wednesday, June 29, 2011
Sincerity of New York City Park Smoking Ban Comes Into Question after Just One Ticket Issued in First Month
After one full month of enforcement, New York City's park smoking ban has resulted in the grand total of one ticket, according to an article in the Daily Mail.
According to the article: "It was supposed to be sweeping legislation covering 1,700 parks and 14 miles of coastline. But New York’s ban on smoking in public places has been branded an 'absolute joke' after just one ticket was issued in the first month of the law coming into force. Newly-released data shows that since May 23, around 700 people have been approached by cops for lighting up where they shouldn't have done. Of those just one has actually been given a ticket - and he was a photographer who was goading officers into doing so." ...
"Ida Sanoff, from Brighton Beach, Brooklyn, said: 'The new smoking law is an absolute joke.' She said: 'I have asthma and there are days when I've had to move my chair three times because people, sometimes in groups, sat down near me and started smoking like chimneys. She told the Wall Street Journal that she has even seen people selling cigarettes on the beach since the ban came in. 'It doesn't make sense to put a law into place without any way of enforcing it. Why bother?' she said."
The Rest of the Story
This leads me to question the sincerity of the health activists in trying to convince us that smoking in parks is a substantial public health hazard that is causing such significant health problems that it requires government intervention.
If you believe that an ordinance violation represents a serious threat to the health of innocent bystanders, then you enforce that ordinance. If you truly believe in the cause, then you should believe in it enough to enforce it. And the most important day to enforce it is day 1. Once you set a precedent by not fining anyone, the law loses its teeth and everyone comes to understand that it is basically a show-piece, not a serious piece of health protection.
When we enforced Boston's smoke-free restaurant law the first day it came into effect, we aggressively inspected establishments and levied fines that very day. We meant business, because the pretense for the law was that it was necessary to protect the lives and health of restaurant workers. If you believe in that premise, then you must also believe that it is essential to enforce the law because lives are at stake.
Clearly, New York City health officials are not concerned that much other than comfort is at stake because they don't see smoking in a park as deserving anything more than a warning.
To be clear, I agree with those officials. However, they shouldn't have deceived us in the first place by arguing - before the law went into effect - that it was necessary to address a serious public health problem.
I think Ida Sanoff of Brighton Beach is quite right. If you're not going to enforce a law, if you don't believe in it enough to enforce it, then why enact it in the first place?
When push comes to shove, I believe that health advocates are now essentially acknowledging that this was largely a feel-good ordinance and that it doesn't address any severe public health hazard. Thus, enforcement is (rightly) not a priority.
Why weren't the health groups honest with us before the ordinance was passed?
According to the article: "It was supposed to be sweeping legislation covering 1,700 parks and 14 miles of coastline. But New York’s ban on smoking in public places has been branded an 'absolute joke' after just one ticket was issued in the first month of the law coming into force. Newly-released data shows that since May 23, around 700 people have been approached by cops for lighting up where they shouldn't have done. Of those just one has actually been given a ticket - and he was a photographer who was goading officers into doing so." ...
"Ida Sanoff, from Brighton Beach, Brooklyn, said: 'The new smoking law is an absolute joke.' She said: 'I have asthma and there are days when I've had to move my chair three times because people, sometimes in groups, sat down near me and started smoking like chimneys. She told the Wall Street Journal that she has even seen people selling cigarettes on the beach since the ban came in. 'It doesn't make sense to put a law into place without any way of enforcing it. Why bother?' she said."
The Rest of the Story
This leads me to question the sincerity of the health activists in trying to convince us that smoking in parks is a substantial public health hazard that is causing such significant health problems that it requires government intervention.
If you believe that an ordinance violation represents a serious threat to the health of innocent bystanders, then you enforce that ordinance. If you truly believe in the cause, then you should believe in it enough to enforce it. And the most important day to enforce it is day 1. Once you set a precedent by not fining anyone, the law loses its teeth and everyone comes to understand that it is basically a show-piece, not a serious piece of health protection.
When we enforced Boston's smoke-free restaurant law the first day it came into effect, we aggressively inspected establishments and levied fines that very day. We meant business, because the pretense for the law was that it was necessary to protect the lives and health of restaurant workers. If you believe in that premise, then you must also believe that it is essential to enforce the law because lives are at stake.
Clearly, New York City health officials are not concerned that much other than comfort is at stake because they don't see smoking in a park as deserving anything more than a warning.
To be clear, I agree with those officials. However, they shouldn't have deceived us in the first place by arguing - before the law went into effect - that it was necessary to address a serious public health problem.
I think Ida Sanoff of Brighton Beach is quite right. If you're not going to enforce a law, if you don't believe in it enough to enforce it, then why enact it in the first place?
When push comes to shove, I believe that health advocates are now essentially acknowledging that this was largely a feel-good ordinance and that it doesn't address any severe public health hazard. Thus, enforcement is (rightly) not a priority.
Why weren't the health groups honest with us before the ordinance was passed?
Tuesday, June 28, 2011
Another Anti-Tobacco Advocate Accuses Electronic Cigarette Companies of Promoting Tobacco Use and Being Funded by Big Tobacco
Why Can't This Issue Be Debated Based on the Facts?
A column by an anti-tobacco advocate on a San Francisco Chronicle blog argues that electronic cigarettes are being marketed in an effort to increase tobacco use and accuses tobacco companies of being behind these efforts.
According to the column: "E-cigs are only one of the latest tricks in pushing tobacco to people, and to subverting anti-tobacco education and restrictions. Unhealthy components have been found therein; the FDA is fighting to regulate them as a drug delivery device, as with regular cigarettes. The World Health Association denies that e-cigs are a legitimate smoking cessation method. Canada holds that e-cigs pose similar nicotine addiction risks and banned them. Former Governor Schwarzenegger vetoed a bill that would have banned their sale in California. They are banned in some public places in other states, and on flights. They can't be sold to minors but have been flavored with fruit and candy. The nicotine content in some e-cigs has been understated in labels and is sometimes much higher than in legitimate smoking cessation products. These supposedly "safer" cigarettes undermine secondhand smoke regulations and make them harder to enforce. And so on....
So, some open questions:
1. Are "thehealthyconsumer" and other e-cig marketing sites and advertising funded by tobacco companies?
2. Does sfgate have policy regarding accepting advertising from tobacco companies? Was this advertisement/link looked at in light of such policy?
3. Do "The Doctors" from television know that their brief 2009 segment on e-cigs is being used as marketing for the devices? If so, have they received any funding from tobacco interests?"
The Rest of the Story
Both major contentions of the commentary are not only wrong, but exactly the opposite of the truth.First, electronic cigarettes are not being marketed to try to increase tobacco use; they are being marketed to try to decrease tobacco use by getting people off of tobacco cigarettes. The goal of every c-cigarette company is to encourage smokers to switch from tobacco cigarettes to electronic (non-tobacco) cigarettes. The fewer tobacco cigarettes the smoker uses, the more money the e-cigarette companies make. So their success is directly tied to the degree to which they are able to lower tobacco sales.
Research, such as my own study published in the American Journal of Preventive Medicine, has documented that electronic cigarettes decrease tobacco use, rather than increase it. The majority of e-cigarette users cut down on the number of tobacco cigarettes they smoke and a proportion are able to quit smoking entirely. There is no evidence of any significant use of electronic cigarettes by youth or nonsmokers. Thus, I do not understand how one can claim that electronic cigarettes are designed to increase tobacco use. The truth is just the opposite. Electronic cigarettes represent a threat to tobacco sales.
The second major contention of the commentary - its accusation that Big Tobacco is behind the marketing of electronic cigarettes - is also false. None of the current electronic cigarette companies - producers or distributors - are associated with tobacco companies. In fact, they are competing directly with tobacco companies (and pharmaceutical companies) for profits.
Given the novelty of these devices and the limited research on their safety and effectiveness, there is plenty of room for healthy debate about the proper role for electronic cigarettes in smoking cessation strategy. However, that debate must be based on the truth - on factual evidence - not on a "pack of lies."
Monday, June 27, 2011
FDA Warns Public of Heart Attack Risks Associated with Chantix; No Anti-Smoking Groups Inform Their Constituents
On June 16, the Food and Drug Administration (FDA) warned the public that Chantix appears to be associated with a small, but significant increase in heart attacks among patients with existing heart disease treated with the drug for smoking cessation.
According to the FDA's statement: "The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk. FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo ... Cardiovascular adverse events were infrequent overall, however, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo."
While the statement cautions that physicians must weigh the benefits of quitting smoking versus any increased risk of cardiovascular events that may be caused by Chantix, the study data do not reveal any net benefit of Chantix-associated smoking cessation. If reduced heart attacks associated with smoking cessation outweighed the increased heart attacks caused by Chantix, then there should have been a lower incidence of non-fatal heart attacks in the treated (Chantix) group. This was not the case. The non-fatal myocardial infarction rate over the one-year follow-up period of the study was 0.9% in the placebo group and 2.0% in the Chantix-treated group.
Thus, within this one year period, the clinical trail failed to demonstrate any net benefit of Chantix in terms of preventing heart attacks within the first ten months of quitting smoking using Chantix.
The Rest of the Story
The rest of the story is that while each of the following groups has called for the removal of electronic cigarettes from the market because of the hypothetical possibility that these devices could have adverse effects - but in the absence of even a single reported serious adverse event - none of these groups have similarly called for the removal of Chantix from the market, nor have they even informed their constituents on their web sites about this new critical information about Chantix-associated severe side effects, even though there are now hundreds of reported suicides and a number of heart attacks associated with Chantix use.
The groups are: the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, Action on Smoking and Health, The American Academy of Pediatrics, and the American Legacy Foundation.
These groups have three things in common:
1. Each has called for the removal of electronic cigarettes from the market, despite the absence of even a single severe adverse reported event
2. Each has refused to call for the removal of Chantix from the market, despite the presence of hundreds of cases of suicides associated with the use of the drug, and now with clear evidence of an increase in heart attacks associated with drug use and no net benefit of the drug in one-year reduction in myocardial infarction
3. Each has refused (from the best of my internet review) to even display the information from last week's FDA statement about the risks of Chantix.
Actually, the groups have an important fourth thing in common:
4. They all have or have had financial associations with Pfizer, the manufacturer of Chantix.
I am not in this commentary calling on the removal or non-removal of Chantix from the market. What I am calling for, however, is consistency in the way in which public health groups evaluate and analyze public health policy issues. Systematic bias should not be a part of the public health evaluation of policy, and such a systematic bias should never enter into the picture because of financial conflicts of interest, especially ones which are not readily disclosed.
According to the FDA's statement: "The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk. FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo ... Cardiovascular adverse events were infrequent overall, however, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo."
While the statement cautions that physicians must weigh the benefits of quitting smoking versus any increased risk of cardiovascular events that may be caused by Chantix, the study data do not reveal any net benefit of Chantix-associated smoking cessation. If reduced heart attacks associated with smoking cessation outweighed the increased heart attacks caused by Chantix, then there should have been a lower incidence of non-fatal heart attacks in the treated (Chantix) group. This was not the case. The non-fatal myocardial infarction rate over the one-year follow-up period of the study was 0.9% in the placebo group and 2.0% in the Chantix-treated group.
Thus, within this one year period, the clinical trail failed to demonstrate any net benefit of Chantix in terms of preventing heart attacks within the first ten months of quitting smoking using Chantix.
The Rest of the Story
The rest of the story is that while each of the following groups has called for the removal of electronic cigarettes from the market because of the hypothetical possibility that these devices could have adverse effects - but in the absence of even a single reported serious adverse event - none of these groups have similarly called for the removal of Chantix from the market, nor have they even informed their constituents on their web sites about this new critical information about Chantix-associated severe side effects, even though there are now hundreds of reported suicides and a number of heart attacks associated with Chantix use.
The groups are: the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, Action on Smoking and Health, The American Academy of Pediatrics, and the American Legacy Foundation.
These groups have three things in common:
1. Each has called for the removal of electronic cigarettes from the market, despite the absence of even a single severe adverse reported event
2. Each has refused to call for the removal of Chantix from the market, despite the presence of hundreds of cases of suicides associated with the use of the drug, and now with clear evidence of an increase in heart attacks associated with drug use and no net benefit of the drug in one-year reduction in myocardial infarction
3. Each has refused (from the best of my internet review) to even display the information from last week's FDA statement about the risks of Chantix.
Actually, the groups have an important fourth thing in common:
4. They all have or have had financial associations with Pfizer, the manufacturer of Chantix.
I am not in this commentary calling on the removal or non-removal of Chantix from the market. What I am calling for, however, is consistency in the way in which public health groups evaluate and analyze public health policy issues. Systematic bias should not be a part of the public health evaluation of policy, and such a systematic bias should never enter into the picture because of financial conflicts of interest, especially ones which are not readily disclosed.
Sunday, June 19, 2011
Wednesday, June 15, 2011
San Clemente Considering Park Smoking Ban
Outdoor smoking bans in wide-open places like parks are spreading rapidly. Today, I report that San Clemente (California) is considering an ordinance that would ban smoking in all parks.
According to an article in the Orange County Register, smoking is already banned "on the city's beaches, on all city-operated trails and in designated canyons" and "within 25 feet of a playground."
City officials met last night to discuss the ban. As of the time this article went to press, I had not yet heard the result of last night's meeting.
The Rest of the Story
It is not clear what the justification for this proposed policy is. Since smoking is already banned on all beaches and on all city-operated trails and in canyons and within 25 feet of a playground, what is the substantial public health hazard that necessitates this policy?
As I argued in my op-ed in the New York Times: "in trying to convince people that even transient exposure to secondhand smoke is a potentially deadly hazard, smoking opponents risk losing scientific credibility. The antismoking movement has always fought with science on its side, but New York’s ban on outdoor smoking seems to fulfill its opponents’ charge that the movement is being driven instead by an unthinking hatred of tobacco smoke. That, in turn, could jeopardize more important fronts in the antismoking fight, in particular the 21 states that still allow smoking in bars and restaurants."
According to an article in the Orange County Register, smoking is already banned "on the city's beaches, on all city-operated trails and in designated canyons" and "within 25 feet of a playground."
City officials met last night to discuss the ban. As of the time this article went to press, I had not yet heard the result of last night's meeting.
The Rest of the Story
It is not clear what the justification for this proposed policy is. Since smoking is already banned on all beaches and on all city-operated trails and in canyons and within 25 feet of a playground, what is the substantial public health hazard that necessitates this policy?
As I argued in my op-ed in the New York Times: "in trying to convince people that even transient exposure to secondhand smoke is a potentially deadly hazard, smoking opponents risk losing scientific credibility. The antismoking movement has always fought with science on its side, but New York’s ban on outdoor smoking seems to fulfill its opponents’ charge that the movement is being driven instead by an unthinking hatred of tobacco smoke. That, in turn, could jeopardize more important fronts in the antismoking fight, in particular the 21 states that still allow smoking in bars and restaurants."
Tuesday, June 14, 2011
NRT and Chantix Proving to Be Less and Less Effective as Studies Approach Real-Life Conditions
Most of the research leading anti-smoking advocates to view nicotine replacement therapy (NRT) and medications like Chantix as effective for smoking cessation involves clinical trials in which subjects received intensive interaction with research staff, including counseling, interviews, and repeat phone calls. However, in real life (outside of the setting of clinical trials), the situation is very different. Some have therefore questioned whether the effectiveness rates of NRT and Chantix in clinical trials is indicative of their likely actual effectiveness as they would be typically used on a population basis.
New research published online ahead of print in the journal Nicotine and Tobacco Research suggests that in more real-life settings, the effectiveness of Chantix is far below that which has been previously reported in clinical trials. While six-month abstinence rates with Chantix as high as 33.5% were reported in the drug's original FDA approval studies, the current study reports only a 14% six-month point-prevalence (7-day) abstinence rate with Chantix (compared to 7% for placebo).
The population in this study consisted of smokers who wanted to quit but had no quit attempt planned in the next month.
The Rest of the Story
In the current study, subjects were provided with just 8 support/counseling sessions compared to 19 in the original Chantix clinical trial. As John Polito points out, the real question is what the six-month abstinence rate would be for the use of Chantix without any support and counseling sessions, as is the case most typically with the population-based use of this drug for smoking cessation.
This research suggests that as the number of support sessions falls and the intervention approaches a real-life situation, the effectiveness of the medication falls quite drastically.
Of note, the same lead study author has previously reported a six-month abstinence rate of only 7% for over-the-counter use of nicotine replacement therapy. This is again much closer to the real-life situation than many clinical trials.
The rest of the story is that tobacco control advocates and researchers are grossly over-estimating the effectiveness of existing, FDA-approved pharmaceutical smoking cessation aids such as nicotine replacement therapy and Chantix because the clinical trial setting with intensive intervention, counseling, and support does not simulate the real-life situation in which most of the population is using these drugs.
It's quite interesting that many tobacco control researchers are questioning the use of electronic cigarettes because they have not been shown to be effective for smoking cessation, yet these same researchers have no problem recommending for widespread use an approach that appears to fail at least 93% of the time.
(Thanks to John Polito for the tip, and for the many insights that I incorporated into this post).
New research published online ahead of print in the journal Nicotine and Tobacco Research suggests that in more real-life settings, the effectiveness of Chantix is far below that which has been previously reported in clinical trials. While six-month abstinence rates with Chantix as high as 33.5% were reported in the drug's original FDA approval studies, the current study reports only a 14% six-month point-prevalence (7-day) abstinence rate with Chantix (compared to 7% for placebo).
The population in this study consisted of smokers who wanted to quit but had no quit attempt planned in the next month.
The Rest of the Story
In the current study, subjects were provided with just 8 support/counseling sessions compared to 19 in the original Chantix clinical trial. As John Polito points out, the real question is what the six-month abstinence rate would be for the use of Chantix without any support and counseling sessions, as is the case most typically with the population-based use of this drug for smoking cessation.
This research suggests that as the number of support sessions falls and the intervention approaches a real-life situation, the effectiveness of the medication falls quite drastically.
Of note, the same lead study author has previously reported a six-month abstinence rate of only 7% for over-the-counter use of nicotine replacement therapy. This is again much closer to the real-life situation than many clinical trials.
The rest of the story is that tobacco control advocates and researchers are grossly over-estimating the effectiveness of existing, FDA-approved pharmaceutical smoking cessation aids such as nicotine replacement therapy and Chantix because the clinical trial setting with intensive intervention, counseling, and support does not simulate the real-life situation in which most of the population is using these drugs.
It's quite interesting that many tobacco control researchers are questioning the use of electronic cigarettes because they have not been shown to be effective for smoking cessation, yet these same researchers have no problem recommending for widespread use an approach that appears to fail at least 93% of the time.
(Thanks to John Polito for the tip, and for the many insights that I incorporated into this post).
Monday, June 13, 2011
Anti-Smoking Advocates Decry Major Smoking Cessation Effort
In an article published online ahead of print in the journal Tobacco Control, a group of tobacco control researchers are attacking electronic cigarette companies for promoting their products by partnering with the entertainment industry and celebrities (see: Grana RA, Glantz SA, Ling PM. Electronic nicotine delivery systems in the hands of Hollywood. Tobacco Control, June 9, 2011).
The article decries the use of an electronic cigarette by Katherine Heigl during her appearance on "The Late Show with David Lettermen," where she stated that she was using the device to quit smoking. It also decries the featuring of electronic cigarettes as a health innovation on the talk show "The Doctors."
According to the article: "In the past, the tobacco industry has partnered with entertainment executives and celebrities to employ several strategies to promote their products in television, movies and popular culture, including cross promotion, product placement and systematic supply of free products to entertainment industry members. It appears that the ENDS [electronic nicotine delivery systems] manufacturers are adopting similar tactics. Given the substantial research demonstrating the effect of viewing smoking in the movies on adolescent smoking initiation, the addictive nature of nicotine and the lack of regulatory assurance of their quality or safety, it is important to keep ENDS, and other similar products, from being sensationalized through the use of celebrity promotion or product placement in movies or other entertainment media."
The Rest of the Story
First, it is not clear to me that this situation is analogous to the tobacco industry's partnerships with Hollywood to promote cigarette smoking because I am aware of no evidence that these depictions of vaping on television were paid for by electronic cigarette companies. Is it not possible that Katherine Heigl decided to demonstrate vaping on television on her own, rather than as a result of having received an electronic cigarette company payment to do so? And is it not possible that the physicians on "The Doctors" actually believe that electronic cigarettes are an important health-related innovation, rather than that they were paid off by e-cigarette manufacturers to promote these devices?
Since the article presents no evidence to support its contention that the electronic cigarette companies had a hand in either of these events, I find its conclusion that the electronic cigarette companies are behind these depictions to be unsupported and therefore inappropriate.
More importantly, though, the paper seems to miss the point. The promotion of electronic cigarettes in the entertainment media and by celebrities is a bad thing only if these devices are actually ineffective for smoking cessation and/or significantly harmful to users. If they are much less harmful than cigarettes and they are helping people to quit smoking, then the promotion of this product in the entertainment media and by celebrities is a great thing and it could save thousands of lives.
The best available evidence at the present time supports the conclusion that electronic cigarettes are much safer than cigarettes and that they are helping thousands of ex-smokers to stay off tobacco cigarettes. Thus, it is most likely the case that the promotion of electronic cigarettes on entertainment television is a good thing because it may be stimulating smokers to quit by trying these unique devices.
In essence, these researchers are criticizing an intervention that is encouraging people to quit smoking. Why would we want to do this? Isn't smoking cessation something we should be encouraging, not attacking?
The problem, of course, is that smokers are not quitting the way we want them to quit. It is not about quitting smoking, it is about quitting smoking the right way. Our way. The way that lines our pockets because of the numerous financial contributions that pharmaceutical companies make to anti-smoking organizations. The way that expert panel members who received payments from these pharmaceutical companies recommend. The way that is least effective because the success rate of NRT treatment is so dismally low.
I guess if it threatens the coffers of anti-smoking organizations, then it's not the right way to quit. And if it simulates smoking - even if much safer - it's definitely not the right way to quit, no matter how effective it may be.
The article decries the use of an electronic cigarette by Katherine Heigl during her appearance on "The Late Show with David Lettermen," where she stated that she was using the device to quit smoking. It also decries the featuring of electronic cigarettes as a health innovation on the talk show "The Doctors."
According to the article: "In the past, the tobacco industry has partnered with entertainment executives and celebrities to employ several strategies to promote their products in television, movies and popular culture, including cross promotion, product placement and systematic supply of free products to entertainment industry members. It appears that the ENDS [electronic nicotine delivery systems] manufacturers are adopting similar tactics. Given the substantial research demonstrating the effect of viewing smoking in the movies on adolescent smoking initiation, the addictive nature of nicotine and the lack of regulatory assurance of their quality or safety, it is important to keep ENDS, and other similar products, from being sensationalized through the use of celebrity promotion or product placement in movies or other entertainment media."
The Rest of the Story
First, it is not clear to me that this situation is analogous to the tobacco industry's partnerships with Hollywood to promote cigarette smoking because I am aware of no evidence that these depictions of vaping on television were paid for by electronic cigarette companies. Is it not possible that Katherine Heigl decided to demonstrate vaping on television on her own, rather than as a result of having received an electronic cigarette company payment to do so? And is it not possible that the physicians on "The Doctors" actually believe that electronic cigarettes are an important health-related innovation, rather than that they were paid off by e-cigarette manufacturers to promote these devices?
Since the article presents no evidence to support its contention that the electronic cigarette companies had a hand in either of these events, I find its conclusion that the electronic cigarette companies are behind these depictions to be unsupported and therefore inappropriate.
More importantly, though, the paper seems to miss the point. The promotion of electronic cigarettes in the entertainment media and by celebrities is a bad thing only if these devices are actually ineffective for smoking cessation and/or significantly harmful to users. If they are much less harmful than cigarettes and they are helping people to quit smoking, then the promotion of this product in the entertainment media and by celebrities is a great thing and it could save thousands of lives.
The best available evidence at the present time supports the conclusion that electronic cigarettes are much safer than cigarettes and that they are helping thousands of ex-smokers to stay off tobacco cigarettes. Thus, it is most likely the case that the promotion of electronic cigarettes on entertainment television is a good thing because it may be stimulating smokers to quit by trying these unique devices.
In essence, these researchers are criticizing an intervention that is encouraging people to quit smoking. Why would we want to do this? Isn't smoking cessation something we should be encouraging, not attacking?
The problem, of course, is that smokers are not quitting the way we want them to quit. It is not about quitting smoking, it is about quitting smoking the right way. Our way. The way that lines our pockets because of the numerous financial contributions that pharmaceutical companies make to anti-smoking organizations. The way that expert panel members who received payments from these pharmaceutical companies recommend. The way that is least effective because the success rate of NRT treatment is so dismally low.
I guess if it threatens the coffers of anti-smoking organizations, then it's not the right way to quit. And if it simulates smoking - even if much safer - it's definitely not the right way to quit, no matter how effective it may be.
Thursday, June 09, 2011
Investigators Running Lung Cancer Detection Trial Cannot Locate Informed Consent Forms; Unclear if Informed Consent Was Obtained from Patients
According to an article in the New York Times, investigators running a trial to determine whether CT screening for lung cancer is effective in reducing mortality rates cannot locate 90% of the informed consent forms, casting doubt on whether consent was appropriately obtained for tens of thousands of patients who were subjected to significant quantities of radiation.
According to the article: "In medical experiments on human beings, every patient must sign an “informed consent” form acknowledging the risks, and researchers are required to keep track of those statements. But the doctors who conducted a controversial, widely publicized lung cancer study involving more than 50,000 patients at numerous hospitals were unable to locate 90 percent of the consent forms, according to a confidential review provided to The New York Times. The finding casts further doubt on a clinical trial that made headlines in 2006 when it concluded that fully 80 percent of lung cancer deaths could be prevented through wide use of CT scans."
A scientific reviewer who was called in to assess the situation is quoted in the article as stating that he has no confidence that informed consent was actually obtained for tens of thousands of patients: "One reviewer, Dr. David P. Carbone, a professor of medicine and cancer biology at Vanderbilt, said in an interview that he and the other reviewers never found out 'whether these consents were obtained and lost or whether they weren’t obtained at all.'"
One medical journal that published work from the research - entitled the International Early Lung Cancer Action Program (ELCAP) - stated that it would be forced to retract that article if the consent forms cannot be located: "Dr. Bruce A. Chabner, director of clinical research at Massachusetts General Hospital Cancer Center and editor in chief of The Oncologist journal, said he would ask Weill Cornell for an explanation of the problems outlined in the 2008 scientific review, as well as a follow-up to the report. His journal has published research by Dr. Henschke, and 'if we find there was no informed consent for those patients, the paper would have to retracted,' he said."
The Rest of the Story
This appears to be a very serious violation of responsible research conduct. It is particularly troubling because this is not a minimal risk study. Subjects in the ELCAP trial are subjected to significant doses of radiation, which itself presents a small cancer risk. If subjects were entered into the trial without informed consent, this would be a major ethical breach.
A single CT scan can expose a patient to the equivalent amount of radiation as up to 442 chest x-rays. Some researchers have estimated that radiation delivered by CT scans in one year will result in a total of 29,000 future cases of cancer. Thus, the risks to which patients were exposed in the ELCAP trial are not trivial and the failure to be able to document informed consent is a major problem.
Long-time readers of the Rest of the Story may recognize that this is not the first time this research has been the subject of a commentary. The institution where the bulk of the research was conducted - the Weill Cornell Medical College - was awarded my Pants On Fire Runner-Up Award in 2009 for falsely claiming that an apology was made for its investigators' failure to disclose a significant conflict of interest in their article on the role of low-dose CT scans in screening for lung cancer.
That financial interest: the principal investigator of the study receives royalties from General Electric on intellectual property she invented which involves the use of CT scanning for early diagnosis of lung cancer, intellectual property which was licensed to General Electric.
Thus, the investigator stands to gain financially if CT scanning is found to be effective in reducing cancer mortality. I wonder if this fact was disclosed to study participants. My personal view is that it would have been unethical not to inform patients of this financial conflict of interest.
Sadly, the rest of the story is that the researchers cannot even document that informed consent was obtained, much less that the financial conflict of interest was disclosed to potential study participants.
According to the article: "In medical experiments on human beings, every patient must sign an “informed consent” form acknowledging the risks, and researchers are required to keep track of those statements. But the doctors who conducted a controversial, widely publicized lung cancer study involving more than 50,000 patients at numerous hospitals were unable to locate 90 percent of the consent forms, according to a confidential review provided to The New York Times. The finding casts further doubt on a clinical trial that made headlines in 2006 when it concluded that fully 80 percent of lung cancer deaths could be prevented through wide use of CT scans."
A scientific reviewer who was called in to assess the situation is quoted in the article as stating that he has no confidence that informed consent was actually obtained for tens of thousands of patients: "One reviewer, Dr. David P. Carbone, a professor of medicine and cancer biology at Vanderbilt, said in an interview that he and the other reviewers never found out 'whether these consents were obtained and lost or whether they weren’t obtained at all.'"
One medical journal that published work from the research - entitled the International Early Lung Cancer Action Program (ELCAP) - stated that it would be forced to retract that article if the consent forms cannot be located: "Dr. Bruce A. Chabner, director of clinical research at Massachusetts General Hospital Cancer Center and editor in chief of The Oncologist journal, said he would ask Weill Cornell for an explanation of the problems outlined in the 2008 scientific review, as well as a follow-up to the report. His journal has published research by Dr. Henschke, and 'if we find there was no informed consent for those patients, the paper would have to retracted,' he said."
The Rest of the Story
This appears to be a very serious violation of responsible research conduct. It is particularly troubling because this is not a minimal risk study. Subjects in the ELCAP trial are subjected to significant doses of radiation, which itself presents a small cancer risk. If subjects were entered into the trial without informed consent, this would be a major ethical breach.
A single CT scan can expose a patient to the equivalent amount of radiation as up to 442 chest x-rays. Some researchers have estimated that radiation delivered by CT scans in one year will result in a total of 29,000 future cases of cancer. Thus, the risks to which patients were exposed in the ELCAP trial are not trivial and the failure to be able to document informed consent is a major problem.
Long-time readers of the Rest of the Story may recognize that this is not the first time this research has been the subject of a commentary. The institution where the bulk of the research was conducted - the Weill Cornell Medical College - was awarded my Pants On Fire Runner-Up Award in 2009 for falsely claiming that an apology was made for its investigators' failure to disclose a significant conflict of interest in their article on the role of low-dose CT scans in screening for lung cancer.
That financial interest: the principal investigator of the study receives royalties from General Electric on intellectual property she invented which involves the use of CT scanning for early diagnosis of lung cancer, intellectual property which was licensed to General Electric.
Thus, the investigator stands to gain financially if CT scanning is found to be effective in reducing cancer mortality. I wonder if this fact was disclosed to study participants. My personal view is that it would have been unethical not to inform patients of this financial conflict of interest.
Sadly, the rest of the story is that the researchers cannot even document that informed consent was obtained, much less that the financial conflict of interest was disclosed to potential study participants.
Wednesday, June 08, 2011
Globalink: A Forum for Global Groupthink in Tobacco Control
Today, I am going to put forward the argument that Globalink (the international tobacco control list-serve) would be better called GlobalGroupthink. It is a perfect example of the groupthink phenomenon which has gripped the tobacco control movement and which I believe threatens the integrity and scientific credibility of the movement.
"2. Collective rationalization – Members discount warnings and do not reconsider their assumptions."
"3. Belief in inherent morality – Members believe in the rightness of their cause and therefore ignore the ethical or moral consequences of their decisions."
"4. Stereotyped views of out-groups – Negative views of “enemy” make effective responses to conflict seem unnecessary."
"5. Direct pressure on dissenters – Members are under pressure not to express arguments against any of the group’s views."
"6. Self-censorship – Doubts and deviations from the perceived group consensus are not expressed."
"7. Illusion of unanimity – The majority view and judgments are assumed to be unanimous."
"8. Self-appointed ‘mindguards’ – Members protect the group and the leader from information that is problematic or contradictory to the group’s cohesiveness, view, and/or decisions."
When I first joined Globalink, I did so because I believed it would be a valuable way for me and other tobacco control researchers and advocates to share critical research findings, discuss scientific and policy issues, and obtain thoughtful feedback on ideas to advance the tobacco control field.
What I discovered is that Globalink serves precisely the opposite functions. It is a mechanism for preventing critical discussion of research, science, and policy issues in tobacco control. It serves to stifle thoughtful discussion of ideas, suppresses dissenting opinions, and plays out as a forum for malicious individual attacks against researchers, advocates, or citizens who dare to go against the mainstream opinions within the tobacco control movement.
I found this out in an interesting way. We were having a discussion on Globalink about employer policies to refuse to hire smokers. While many of the advocates spoke out in favor of such policies, a small number opposed them. It was suggested that we take an informal vote in order to get a sense of how opinion split on the issue. I thought this was a fair idea and would have helped us to get a sense of where tobacco control advocates’ positions split on the issue.
However, a number of advocates argued vehemently against taking a vote, arguing that if information were made public showing that a significant number of tobacco control advocates opposed these policies, it would give ammunition to “our opponents.” This point of view carried the day and the vote was quashed.
This move not only prevented a vote and ensured that we would never know the extent of opposition workplace smoker bans, but it also sent a message to everyone on the list-serve that support of such bans is the “official” dogma of the movement and that anyone who dares express disagreement to such policies is viewed as the “opposition.” Thus, this move made a clear statement that expressing disagreement with the idea of refusing to hire smokers was essentially heresy and that by doing so, the dissenter would be cast out of the movement and be viewed and treated as the opposition.
This is but one example, but it demonstrates how groupthink operates on Globalink. For all I know, it Is very possible that the majority of Globalink members actually opposed the refusal to hire smokers. However, because it was made clear that expressing such an opinion would be viewed as heresy, very few were willing to speak out. This, in turn, created the false perception that almost everyone on Globalink supported such measures. In effect, groupthink makes it possible for a group of people who almost all oppose a particular measure to come to the conclusion that they uniformly support such a measure.
I was soon to found out the extent to which groupthink dominates Globalink. I submitted a comment in which I suggested that the strength of scientific evidence supporting the conclusion that smoking bans lead to a dramatic, immediate reduction in heart attacks was not as strong as being asserted by many anti-smoking groups. Instead of responses that took issue with my interpretation of the scientific evidence, I was met with a defamatory personal attack: an accusation that I am a “traitor” who has gone to the other side and who now takes tobacco industry money.
In addition to personal attacks, there were also calls for me to be removed from Globalink for having the gall to express disagreement with one of the most entrenched pieces of dogma in the movement: that all research demonstrating adverse effects of secondhand smoke or positive effects of bans must be correct.
While most people are deterred by these personal attacks and defamatory accusations, I remained undeterred, somehow withstanding getting pummeled by my own colleagues. I continued to express my opinions, which from time to time, differed with those of the mainstream. Eventually, the inevitable happened. Globalink and its members had enough of my willingness to express disagreement, and I was expelled from the list-serve.
During my time on Globalink, I witnessed vicious personal attacks against any and all opponents of tobacco control policies, including private citizens who had no affiliation with tobacco companies. It was a forum for mud-slinging against anyone who dares to disagree with “our” point-of-view on the issues.
One of the characteristics of groupthink is that by insulating the group from criticism or differing opinions, the scientific rigor and integrity of the group gradually dissipates. Without being subject to challenge, scientific arguments and evidence begin to fail. No reputable scientist insulates herself from criticism or challenge. In fact, it is by subjecting ourselves to constant challenge that scientists are able to ensure the quality of their work and the accuracy of their conclusions. The very best scientists actually try to knock down their own arguments and do not draw conclusions until they are able to address every reasonable alternative hypothesis.
This process is not possible with groupthink. And this is why groupthink destroys the scientific integrity and credibility of social movements.
The Rest of the Story
Social psychologist Irving Janis coined the term groupthink and listed eight characteristics:
"1. Illusion of invulnerability – Creates excessive optimism that encourages taking extreme risks.""2. Collective rationalization – Members discount warnings and do not reconsider their assumptions."
"3. Belief in inherent morality – Members believe in the rightness of their cause and therefore ignore the ethical or moral consequences of their decisions."
"4. Stereotyped views of out-groups – Negative views of “enemy” make effective responses to conflict seem unnecessary."
"5. Direct pressure on dissenters – Members are under pressure not to express arguments against any of the group’s views."
"6. Self-censorship – Doubts and deviations from the perceived group consensus are not expressed."
"7. Illusion of unanimity – The majority view and judgments are assumed to be unanimous."
"8. Self-appointed ‘mindguards’ – Members protect the group and the leader from information that is problematic or contradictory to the group’s cohesiveness, view, and/or decisions."
Each of these eight characteristics was present in Globalink (and is present more generally within the tobacco control movement). Below, I provide one example of each of these characteristics.
"1. Illusion of invulnerability – Creates excessive optimism that encourages taking extreme risks."
I witnessed an illusion of invulnerability regarding the scientific evidence related to secondhand smoke and the effectiveness of smoking bans. There can be no scientific study reporting adverse effects of secondhand smoke that is weak or wrong. There can be no scientific study reporting benefits of smoking bans that is weak or wrong. Thus, anti-smoking groups are willing to take great risks with respect to the claims they are willing to make about the effects of brief secondhand smoke exposure and about the immediate cardiovascular benefits of smoking bans. The normal carefulness that would temper extreme claims largely does not operate when it comes to this aspect of the tobacco control movement.
"2. Collective rationalization – Members discount warnings and do not reconsider their assumptions."
The perfect example of this is policy regarding electronic cigarettes compared to Chantix. Anti-smoking groups have been unwilling to reconsider their assumptions regarding the role of harm reduction in tobacco control, even though electronic cigarettes are not manufactured by tobacco companies, contain no tobacco, and involve no combustion. Anti-smoking groups have also discounted warnings regarding the life-threatening effects of Chantix and thus find themselves in the absurd situation of calling for a ban on electronic cigarettes, which have killed no one, while promoting the continued availability of Chantix, which has been associated with more than 200 suicides. Anti-smoking groups are not willing to reconsider their basic assumptions.
"3. Belief in inherent morality – Members believe in the rightness of their cause and therefore ignore the ethical or moral consequences of their decisions."
Anti-smoking groups too often justify unethical behavior, personal attacks on others, or receipt of funding from corporations with conflicting interests by arguing that the cause is a good one, so these pitfalls are justified. A perfect example of this was the American Legacy Foundation's argument that its taking tobacco money to fund anti-smoking ads was acceptable because the cause was a good one, but that nobody else could take tobacco money because by doing so they were contributing to the public relations work of the evil tobacco companies.
"4. Stereotyped views of out-groups – Negative views of “enemy” make effective responses to conflict seem unnecessary."
Anyone who opposes tobacco control dogma is viewed as the enemy and is personally attacked. Globalink is loaded with these personal attacks on opponents. The opponents are viewed in a stereotypic way and factual evidence is not needed to support attacks on these individuals.
"5. Direct pressure on dissenters – Members are under pressure not to express arguments against any of the group’s views."
My expulsion from Globalink, as well as the efforts to directly suppress opposing viewpoints are perfect illustrations of this fifth characteristic of groupthink.
"6. Self-censorship – Doubts and deviations from the perceived group consensus are not expressed."
I cannot tell you how many times I would receive phone calls after one of my posts to Globalink thanking me and telling me how much the individual agreed with me and was grateful that I had the courage to express my dissenting opinion. However, very few of these advocates were willing to share their opinions publicly. Self-censorship is rampant in the tobacco control movement.
"7. Illusion of unanimity – The majority view and judgments are assumed to be unanimous."
The effect of this self-censorship is an illusion of unanimity. Because dissent is discouraged or quelled and individuals do not feel free to disagree, an illusion of unanimity is created.
"8. Self-appointed ‘mindguards’ – Members protect the group and the leader from information that is problematic or contradictory to the group’s cohesiveness, view, and/or decisions."
The actions of the Globalink leadership to expel me when my opinions threatened the group by being contradictory to its views demonstrate this characteristic in action.
Monday, June 06, 2011
Australia Seizes Electronic Cigarettes, While Allowing Real Ones to Pass Through to Consumers
In a display of the reverse logic that seems to pervade the tobacco control movement these days, Australia has seized and destroyed 70 packages of relatively harmless electronic cigarettes, while allowing millions of deadly, real ones to continue through to consumers.
According to an article in the Morning Bulletin, these dangerous products that were seized have the following scary properties: "[they] emit a harmless water vapour to give the feel of smoking but don’t contain the bad odour, carbon monoxide, tar and ash of a normal cigarette."
The Rest of the Story
Yesterday, I demonstrated the reverse logic of health officials in Linn County (Iowa), who are considering banning dissolvable tobacco products to "protect youth." Yet the truth is that youths don't use dissolvable tobacco products and the ordinance exempts the very products that the youths of Linn County do use.
Today is another demonstration of the reverse logic prevalent today in tobacco control. Health officials in Australia have banned a relatively safe product that delivers nicotine without thousands of toxins and carcinogens, yet they are allowing the real cigarettes - which deliver more than 60 known carcinogens - to remain unchecked.
Check out this logic:
Number of deaths from cigarettes each year in Australia: More than 15,000
Number of deaths from electronic cigarettes each year in Australia: 0
Status of cigarettes: Legal
Status of electronic cigarettes: Illegal
This logic makes no sense. If anything, what it does is help to protect entrenched tobacco industry sales. The tobacco industry could ask for no greater help than to shield itself from the threat of losing business due to electronic cigarettes.
According to an article in the Morning Bulletin, these dangerous products that were seized have the following scary properties: "[they] emit a harmless water vapour to give the feel of smoking but don’t contain the bad odour, carbon monoxide, tar and ash of a normal cigarette."
The Rest of the Story
Yesterday, I demonstrated the reverse logic of health officials in Linn County (Iowa), who are considering banning dissolvable tobacco products to "protect youth." Yet the truth is that youths don't use dissolvable tobacco products and the ordinance exempts the very products that the youths of Linn County do use.
Today is another demonstration of the reverse logic prevalent today in tobacco control. Health officials in Australia have banned a relatively safe product that delivers nicotine without thousands of toxins and carcinogens, yet they are allowing the real cigarettes - which deliver more than 60 known carcinogens - to remain unchecked.
Check out this logic:
Number of deaths from cigarettes each year in Australia: More than 15,000
Number of deaths from electronic cigarettes each year in Australia: 0
Status of cigarettes: Legal
Status of electronic cigarettes: Illegal
This logic makes no sense. If anything, what it does is help to protect entrenched tobacco industry sales. The tobacco industry could ask for no greater help than to shield itself from the threat of losing business due to electronic cigarettes.
Linn County Health Officials Want to Ban Dissolvable Tobacco Products (Which Kids Don't Use) and Keep Cigarettes (Which Many Kids Do Use) Available
Apparently wanting to make sure that kids in Linn County, Iowa will continue to have access to their tobacco product of choice - cigarettes - health officials in that county are urging the County Board of Supervisors to pass a law that bans the sale of tobacco products, but exempts the most popular types of tobacco products among kids: cigarettes and traditional smokeless tobacco products like snuff and chewing tobacco.
In fact, the only type of tobacco product for which a ban is recommended by county health officials is dissolvable tobacco products (like Ariva and Stonewall), which are exceedingly unpopular among youths.
Ironically, the entire premise of the proposed policy, according to health officials, is to "protect youth."
According to an Eastern Iowa Health article: "Linn County Public Health received a $2 million, two-year Communities Putting Prevention to Work grant last year through the U.S. Department of Health and Human Services to target tobacco policies."
The Rest of the Story
If this is how the $2 million of federal taxpayer money is being used, then it is being spent in exactly the opposite way that it should.
This policy targets precisely the least popular type of tobacco product among youth and specifically exempts the most popular tobacco product: cigarettes. Thus, the proposed ordinance does nothing to reduce youth tobacco use in Linn County. It does, however, penalize smokers who may be trying to quit with the use of Ariva or Stonewall.
A study published last year in the journal Nicotine and Tobacco Research demonstrated that the use of Ariva/Stonewall "led to a significant reduction (40%, 95% CI: 24%–55%) in cigarettes per day, no significant increases in total tobacco use (cigarettes + Ariva/Stonewall; p > .05), and significant increases in two measures of readiness to quit, either in the next month (p < .001) or within the next 6 months (p = .04), as well as significant increases in self-efficacy to quit smoking (p < .001)."
The researchers conclude: "this study suggests a strong need for a large prospective randomized clinical trial to more accurately assess the long-term viability of smokeless tobacco use as a method for cessation induction among unmotivated smokers."
I guess they won't be conducting that trial in Linn County. There, they seem to be eager to take off the market a product which is safer than cigarette smoking and which could potentially be helping some smokers to quit, under the guise of "protecting youth." But how exactly does it protect youth to ban a product which those youth are not using? And to exempt from the ban the precise products which are most popular among those youth?
The logic among Linn County health officials is exactly reversed. This is similar to the reversed logic among national anti-smoking groups, which supported FDA tobacco legislation that institutionalizes the FDA's seal of approval for the most toxic tobacco products on the market - cigarettes - and puts insurmountable obstacles that preclude the marketing of safer tobacco products that could potentially save lives.
While Linn County received a $2 million "Communities Putting Prevention to Work" grant last year, I would suggest that this year it needs a $4 million "Communities Putting Logic to Work" grant.
In fact, the only type of tobacco product for which a ban is recommended by county health officials is dissolvable tobacco products (like Ariva and Stonewall), which are exceedingly unpopular among youths.
Ironically, the entire premise of the proposed policy, according to health officials, is to "protect youth."
According to an Eastern Iowa Health article: "Linn County Public Health received a $2 million, two-year Communities Putting Prevention to Work grant last year through the U.S. Department of Health and Human Services to target tobacco policies."
The Rest of the Story
If this is how the $2 million of federal taxpayer money is being used, then it is being spent in exactly the opposite way that it should.
This policy targets precisely the least popular type of tobacco product among youth and specifically exempts the most popular tobacco product: cigarettes. Thus, the proposed ordinance does nothing to reduce youth tobacco use in Linn County. It does, however, penalize smokers who may be trying to quit with the use of Ariva or Stonewall.
A study published last year in the journal Nicotine and Tobacco Research demonstrated that the use of Ariva/Stonewall "led to a significant reduction (40%, 95% CI: 24%–55%) in cigarettes per day, no significant increases in total tobacco use (cigarettes + Ariva/Stonewall; p > .05), and significant increases in two measures of readiness to quit, either in the next month (p < .001) or within the next 6 months (p = .04), as well as significant increases in self-efficacy to quit smoking (p < .001)."
The researchers conclude: "this study suggests a strong need for a large prospective randomized clinical trial to more accurately assess the long-term viability of smokeless tobacco use as a method for cessation induction among unmotivated smokers."
I guess they won't be conducting that trial in Linn County. There, they seem to be eager to take off the market a product which is safer than cigarette smoking and which could potentially be helping some smokers to quit, under the guise of "protecting youth." But how exactly does it protect youth to ban a product which those youth are not using? And to exempt from the ban the precise products which are most popular among those youth?
The logic among Linn County health officials is exactly reversed. This is similar to the reversed logic among national anti-smoking groups, which supported FDA tobacco legislation that institutionalizes the FDA's seal of approval for the most toxic tobacco products on the market - cigarettes - and puts insurmountable obstacles that preclude the marketing of safer tobacco products that could potentially save lives.
While Linn County received a $2 million "Communities Putting Prevention to Work" grant last year, I would suggest that this year it needs a $4 million "Communities Putting Logic to Work" grant.
Friday, June 03, 2011
Physicians for a Smoke-Free Canada Accuses Everyone Who Opposes Outdoor Smoking Bans of Being Funded by Big Tobacco
In its advocacy guide to promoting outdoor smoking bans, Physicians for a Smoke-Free Canada instructs local anti-smoking advocates that all opposition to outdoor smoking bans is orchestrated by the tobacco industry. Those who advocate against such policies are not ordinary citizens, but are front groups or plants from the tobacco industry.
Speaking of initiatives to oppose outdoor smoking bans, Physicians for a Smoke-Free Canada states: "These initiatives are invariably undertaken by tobacco industry front groups or plants, not ordinary citizens. If this is happening in your community, try to follow the money and you’re sure to find the tobacco industry behind the scenes."
The Rest of the Story
According to Physicians for a Smoke-Free Canada, I must be a front group or plant from the tobacco industry because I published an op-ed opposing the outdoor smoking ban in New York City.
I challenge Physicians for a Smoke-Free Canada to "follow the money" and "find the tobacco industry behind the scenes" as they claim is "invariably" the case.
Physicians for a Smoke-Free Canada is demonstrating one of the leading pieces of fallacious dogma in the tobacco control movement: the assumption that all opposition to smoking bans is invariably orchestrated by the tobacco industry and that there is no such thing as an ordinary citizen opposing a smoking ban.
If you take part in secondhand smoke policy training in the tobacco control movement, chances are that you will be taught that all opposition to smoking bans is orchestrated by the tobacco industry, that anyone who challenges the science connecting secondhand smoke exposure and severe health effects is a paid lackey of Big Tobacco, and that any group which disseminates information challenging these health effects is a tobacco industry front group. Consequently, the a chief strategy of tobacco control is to smear the opposition by accusing them of being tobacco industry moles. And in no situation should one say anything positive about an opponent, even if true.
More importantly, if you act in opposition to this dogma, you are cast out of the movement, swiftly and with a one-way ticket. I learned this the hard way.
In 1999, a sentinel event in my career occurred which woke me up to the fact that I had in fact been brainwashed to believe these errant ideas. I wrote an article summarizing some of these ideas. In the article, I suggested that if any group opposes a smoking ban, advocates should not discuss the substance of the opponents' claims, but should instead try to discredit them by exposing their ties to Big Tobacco.
I woke up one morning to find that, without my permission, my article had been posted on the internet by Americans for Nonsmokers' Rights (ANR). Something about having my work published on the world wide web for everyone to see awoke me from my brainwashing and snapped me back to reality. Immediately, I realized that I had made a mistake. I called ANR and asked them to please change the article to reflect a clarification, in which I made it clear that I was not in fact accusing certain individuals who had challenged the severity of secondhand smoke health effects of having personally received money from tobacco companies.
To my shock, ANR refused to accede to my request, even though I was the author of the article. They responded that they did not want to say anything even remotely positive about an opponent and that they had to place their own political agenda ahead of my scientific integrity:
"we have concluded that the possible 'clarification' that you and I discussed is simply not feasible. There is a strong concensus that we do not want to post ANYTHING on our web page that can be construed as an apology or as backtracking from the position taken in the paper you wrote. More specifically, XXXXXX has convinced me that, given XXXXX's long history of attacking ETS science, it would be a mistake to state anything that would give him credence. ... I realize that your views on the matter are heart-felt and sincere, and that mere removal of your name from the paper, without more, will not be entirely satisfactory to you. But at this point ANR must put its political credibility ahead of what you consider to be your scientific credibility."
ANR then decided to completely disrespect my authorship rights and my copyright of the article, and to subsume copyright of the article for itself by publishing it on its website without my name. I never gave ANR permission to do this. What I told ANR clearly was that given its refusal to change my article as I re-wrote it, I wanted the article removed from its website. It was only when ANR refused to honor this author's request that I demanded that my name be removed from its website.
(Read the entire story here)
What turned out to be errant information about the nature of opposition to smoking bans was delivered to me via a systematic method of formal trainings in which these ideas were deliberately spread to me and other tobacco control advocates with the purpose of furthering the anti-smoking cause.
These ideas ran counter to my own pre-conceived and firmly held ideas about the nature of opposition to smoking bans and to challenges of the health effects of secondhand smoke. After all, I had many good friends who challenged the connection between secondhand smoke and chronic disease, so I "knew" that not everyone who challenges the science is a Big Tobacco lackey. I also had met many of the opponents of smoking bans and it never occurred to me that they were tobacco moles. Nevertheless, this wisdom was so strongly imparted upon me in the trainings (which were largely delivered by, or influenced by ANR) that I came to believe this information, even though it was at odds with my pre-conceived beliefs.
Importantly, only one perspective on this issue was presented to us in the trainings. There was no room for disagreement or challenge. These ideas were presented as scientific facts, not subject to debate. In fact, if we were to challenge the ideas, the implication was that we - ourselves - might be accused of working for Big Tobacco or receiving secret payoffs.
This dogma, however, is untrue. While it is certainly the case that most of the scientific challenges to secondhand smoke science came from tobacco industry-funded initiatives, there are a number of scientists and others who have challenged the science but are not paid by Big Tobacco to do so. The American Council on Science and Health, for example, has challenged the strength of the link between secondhand smoke and chronic disease, while acknowledging the acute effects of tobacco smoke. Martha Perske wrote some very well-researched and meticulous critiques of secondhand smoke science. I have myself challenged the claims made by many anti-smoking groups about the acute cardiovascular effects of secondhand smoke. So no - not everyone who suggests that secondhand smoke health claims have been exaggerated is a paid lackey of the tobacco industry.
Now, Physicians for a Smoke-Free Canada is demonstrating how this dogma plays out in practice. I challenge them to demonstrate that what they are instructing local advocates is true. I challenge Physicians for a Smoke-Free Canada to "follow the money" and "find the tobacco industry behind the scenes" as they claim is "invariably" the case.
This is important, because if I've received that money, I need to find it myself. Think of the things I could be doing with it if only I knew where it was.
Speaking of initiatives to oppose outdoor smoking bans, Physicians for a Smoke-Free Canada states: "These initiatives are invariably undertaken by tobacco industry front groups or plants, not ordinary citizens. If this is happening in your community, try to follow the money and you’re sure to find the tobacco industry behind the scenes."
The Rest of the Story
According to Physicians for a Smoke-Free Canada, I must be a front group or plant from the tobacco industry because I published an op-ed opposing the outdoor smoking ban in New York City.
I challenge Physicians for a Smoke-Free Canada to "follow the money" and "find the tobacco industry behind the scenes" as they claim is "invariably" the case.
Physicians for a Smoke-Free Canada is demonstrating one of the leading pieces of fallacious dogma in the tobacco control movement: the assumption that all opposition to smoking bans is invariably orchestrated by the tobacco industry and that there is no such thing as an ordinary citizen opposing a smoking ban.
If you take part in secondhand smoke policy training in the tobacco control movement, chances are that you will be taught that all opposition to smoking bans is orchestrated by the tobacco industry, that anyone who challenges the science connecting secondhand smoke exposure and severe health effects is a paid lackey of Big Tobacco, and that any group which disseminates information challenging these health effects is a tobacco industry front group. Consequently, the a chief strategy of tobacco control is to smear the opposition by accusing them of being tobacco industry moles. And in no situation should one say anything positive about an opponent, even if true.
More importantly, if you act in opposition to this dogma, you are cast out of the movement, swiftly and with a one-way ticket. I learned this the hard way.
In 1999, a sentinel event in my career occurred which woke me up to the fact that I had in fact been brainwashed to believe these errant ideas. I wrote an article summarizing some of these ideas. In the article, I suggested that if any group opposes a smoking ban, advocates should not discuss the substance of the opponents' claims, but should instead try to discredit them by exposing their ties to Big Tobacco.
I woke up one morning to find that, without my permission, my article had been posted on the internet by Americans for Nonsmokers' Rights (ANR). Something about having my work published on the world wide web for everyone to see awoke me from my brainwashing and snapped me back to reality. Immediately, I realized that I had made a mistake. I called ANR and asked them to please change the article to reflect a clarification, in which I made it clear that I was not in fact accusing certain individuals who had challenged the severity of secondhand smoke health effects of having personally received money from tobacco companies.
To my shock, ANR refused to accede to my request, even though I was the author of the article. They responded that they did not want to say anything even remotely positive about an opponent and that they had to place their own political agenda ahead of my scientific integrity:
"we have concluded that the possible 'clarification' that you and I discussed is simply not feasible. There is a strong concensus that we do not want to post ANYTHING on our web page that can be construed as an apology or as backtracking from the position taken in the paper you wrote. More specifically, XXXXXX has convinced me that, given XXXXX's long history of attacking ETS science, it would be a mistake to state anything that would give him credence. ... I realize that your views on the matter are heart-felt and sincere, and that mere removal of your name from the paper, without more, will not be entirely satisfactory to you. But at this point ANR must put its political credibility ahead of what you consider to be your scientific credibility."
ANR then decided to completely disrespect my authorship rights and my copyright of the article, and to subsume copyright of the article for itself by publishing it on its website without my name. I never gave ANR permission to do this. What I told ANR clearly was that given its refusal to change my article as I re-wrote it, I wanted the article removed from its website. It was only when ANR refused to honor this author's request that I demanded that my name be removed from its website.
(Read the entire story here)
What turned out to be errant information about the nature of opposition to smoking bans was delivered to me via a systematic method of formal trainings in which these ideas were deliberately spread to me and other tobacco control advocates with the purpose of furthering the anti-smoking cause.
These ideas ran counter to my own pre-conceived and firmly held ideas about the nature of opposition to smoking bans and to challenges of the health effects of secondhand smoke. After all, I had many good friends who challenged the connection between secondhand smoke and chronic disease, so I "knew" that not everyone who challenges the science is a Big Tobacco lackey. I also had met many of the opponents of smoking bans and it never occurred to me that they were tobacco moles. Nevertheless, this wisdom was so strongly imparted upon me in the trainings (which were largely delivered by, or influenced by ANR) that I came to believe this information, even though it was at odds with my pre-conceived beliefs.
Importantly, only one perspective on this issue was presented to us in the trainings. There was no room for disagreement or challenge. These ideas were presented as scientific facts, not subject to debate. In fact, if we were to challenge the ideas, the implication was that we - ourselves - might be accused of working for Big Tobacco or receiving secret payoffs.
This dogma, however, is untrue. While it is certainly the case that most of the scientific challenges to secondhand smoke science came from tobacco industry-funded initiatives, there are a number of scientists and others who have challenged the science but are not paid by Big Tobacco to do so. The American Council on Science and Health, for example, has challenged the strength of the link between secondhand smoke and chronic disease, while acknowledging the acute effects of tobacco smoke. Martha Perske wrote some very well-researched and meticulous critiques of secondhand smoke science. I have myself challenged the claims made by many anti-smoking groups about the acute cardiovascular effects of secondhand smoke. So no - not everyone who suggests that secondhand smoke health claims have been exaggerated is a paid lackey of the tobacco industry.
Now, Physicians for a Smoke-Free Canada is demonstrating how this dogma plays out in practice. I challenge them to demonstrate that what they are instructing local advocates is true. I challenge Physicians for a Smoke-Free Canada to "follow the money" and "find the tobacco industry behind the scenes" as they claim is "invariably" the case.
This is important, because if I've received that money, I need to find it myself. Think of the things I could be doing with it if only I knew where it was.
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