Last year, New York City Mayor Michael Bloomberg signed legislation that banned the sale of flavored tobacco products in the City. The legislation, unlike federal law, covers all tobacco products, not just cigarettes. Thus, not only are flavored cigarettes banned, but so too are flavored cigars, flavored cigarillos, and flavored smokeless tobacco.
The City Council boasts that this measure is going to reduce youth tobacco use, as many tobacco companies use flavorings to help entice young people to try these products.
The Rest of the Story
If you read the not-so-fine print of the legislation, it makes an exception for menthol, wintergreen, and mint.
Not coincidentally, menthol is the only flavoring that is actually used by cigarette companies to any extent and wintergreen and mint are the primary flavorings used by smokeless tobacco companies.
Thus, the City Council is claiming to care about protecting kids from flavored tobacco, but is actually protecting the tobacco companies' profits from a potential loss of sales that could occur if the Council really did ban the flavored products that young people are consuming.
This is nothing but a ruse. It is designed to make it look like the Council really cares about youth smoking and has the political courage to do something about it, but the reality is that it is an act of political cowardice and blatant hypocrisy.
What the Council is saying is: "We don't really want to have any effect on tobacco profits (thus the exemption for the only flavored products that kids actually consume), but we want to make it look like we are doing something to protect kids. So we are going to get the best of both worlds. Make it look like we actually care and are standing up to Big Tobacco. But don't actually do anything that would engender real political opposition, lower tobacco company profits, or reduce youth tobacco use.
Friday, October 29, 2010
Thursday, October 28, 2010
Single Bowl of Corn Flakes Causes Heart Damage Similar to That of Habitual Smokers, According to Reasoning of ANR and ASH
According to the same reasoning used by Americans for Nonsmokers' Rights (ANR) and Action on Smoking and Health (ASH) in making public statements on the effects of brief secondhand smoke exposure on the heart, eating a single bowl of Corn Flakes can cause heart damage similar to that of habitual smokers.
Moreover, the same reasoning leads to the following pronouncements:
1. Causes heart damage similar to that in habitual smokers (ANR); and
2. Increases a nonsmoker's risk of a fatal heart attack to that of a chronic smoker's (ASH).
The Rest of the Story
What ANR and ASH have not told you is that eating a single bowl of Corn Flakes also causes endothelial dysfunction, bringing your coronary flow velocity reserve to similar levels as observed in active smokers.
Does that mean that eating a single bowl of Corn Flakes "causes heart damage similar to that in habitual smokers"?
Of course not. If any organization made such a claim, it would be attacked - and rightly so. Because it is an inaccurate extrapolation to tell the public that endothelial dysfunction is the same thing as heart damage. Obviously, you don't see cardiologists going around telling their patients not to eat even a single bowl of Corn Flakes because it can cause heart damage similar to that of habitual smokers.
The same phenomenon occurs after eating a single high-fat meal. And after consuming a single energy drink. And after experiencing acute mental stress. But it would obviously be untruthful to tell the public that consuming a single energy drink can cause heart damage similar to that of habitual smokers. Or that a brief episode of mental stress causes heart damage similar to that of habitual smokers. So how could it then be truthful to tell the public that being exposed to secondhand smoke for a mere 30 minutes causes heart damage similar to that in habitual smokers?
The answer is that it is not truthful. Both ASH and ANR are disseminating lies to the public in making these statements, which exaggerate, extrapolate, and distort the science in a way that turns a potentially important piece of information into a lie.
For those interested, here are links to the articles which document impaired endothelial dysfunction, similar to that observed with a 30-minute secondhand smoke exposure, as a result of:
Eating a single bowl of Corn Flakes
Consuming a single high-fat meal
Consuming a single energy drink
Acute mental stress
Moreover, the same reasoning leads to the following pronouncements:
- Eating a single high-fat meal can cause heart damage similar to that of habitual smokers.
- Drinking a single energy drink can cause heart damage similar to that of habitual smokers.
- A brief episode of acute mental stress can cause heart damage similar to that of habitual smokers.
1. Causes heart damage similar to that in habitual smokers (ANR); and
2. Increases a nonsmoker's risk of a fatal heart attack to that of a chronic smoker's (ASH).
The Rest of the Story
What ANR and ASH have not told you is that eating a single bowl of Corn Flakes also causes endothelial dysfunction, bringing your coronary flow velocity reserve to similar levels as observed in active smokers.
Does that mean that eating a single bowl of Corn Flakes "causes heart damage similar to that in habitual smokers"?
Of course not. If any organization made such a claim, it would be attacked - and rightly so. Because it is an inaccurate extrapolation to tell the public that endothelial dysfunction is the same thing as heart damage. Obviously, you don't see cardiologists going around telling their patients not to eat even a single bowl of Corn Flakes because it can cause heart damage similar to that of habitual smokers.
The same phenomenon occurs after eating a single high-fat meal. And after consuming a single energy drink. And after experiencing acute mental stress. But it would obviously be untruthful to tell the public that consuming a single energy drink can cause heart damage similar to that of habitual smokers. Or that a brief episode of mental stress causes heart damage similar to that of habitual smokers. So how could it then be truthful to tell the public that being exposed to secondhand smoke for a mere 30 minutes causes heart damage similar to that in habitual smokers?
The answer is that it is not truthful. Both ASH and ANR are disseminating lies to the public in making these statements, which exaggerate, extrapolate, and distort the science in a way that turns a potentially important piece of information into a lie.
For those interested, here are links to the articles which document impaired endothelial dysfunction, similar to that observed with a 30-minute secondhand smoke exposure, as a result of:
Eating a single bowl of Corn Flakes
Consuming a single high-fat meal
Consuming a single energy drink
Acute mental stress
Tuesday, October 26, 2010
Article on Electronic Cigarettes Draws Conclusion Before Data Are In: Why is the Research Necessary?
A commentary published online ahead of print earlier this month in the journal Tobacco Control reviews the marketing of electronic cigarettes and calls for public health research on these new products to help inform regulatory strategies (see: Noel JK, Rees VW, Connolly GN. Electronic cigarettes: a new 'tobacco' industry? Tobacco Control 2010).
Curiously, however, the article concludes - before any of the research that it calls for has been conducted - that the results of this research should be used "to counteract e-cigarette industry marketing."
The article concludes as follows: "The emergence of the e-cigarette industry must be met with an informed public health response. Research on product design, toxicant exposure, abuse liability including dual use with tobacco products, youth initiation, and influence on cessation efforts is needed to counteract e-cigarette industry marketing and inform regulatory strategies."
In other words, the authors are concluding that research is necessary to inform an appropriate public health response, but that regardless of what the research actually shows, its purpose is simply to provide evidence to counteract e-cigarette marketing: that is, to discourage electronic cigarette use.
Apparently, it doesn't matter what the research actually shows. The authors have apparently drawn a pre-determined conclusion that electronic cigarettes are harmful to the public health and therefore we should discourage people from using these products. But this conclusion precedes the research they call for to determine whether or not the product is safer than regular cigarettes, how effective it is in smoking cessation, and whether or not it encourages youth smoking initiation or dual use with tobacco products.
What then, is the point of the research?
The Rest of the Story
Apparently, the purpose of the research is to support a pre-determined conclusion that we should discourage people from using electronic cigarettes.
But what if the research were to show that electronic cigarettes are very effective in helping people quit smoking and that they are much safer than regular cigarettes (two hypotheses for which there is very strong preliminary evidence)?
I guess it wouldn't matter, because according to this article, we need the research "to counteract e-cigarette industry marketing."
Clearly, according to this article, there is no point in doing the research in the first place. If the pre-determined conclusion is that electronic cigarettes are evil and will harm the public's health, then why waste the money on the research? Why not just ban electronic cigarettes, here and now? Doing the research would actually be devastating to the public's health, as countless lives would be lost from toxicant exposure, dual use, youth initiation, and decreased cessation during the mean time.
On the other hand, if the research ends up confirming preliminary evidence that electronic cigarettes are much safer than regular ones and that they are very helpful to many vapers in keeping them off cigarettes, then efforts to counter electronic cigarette marketing will be contrary to the protection of the public's health, and will end up killing people. How is that a good thing? And why would you want to promote an action that might end up killing people before you have the facts in place?
An additional troubling aspect of this story is that one of the authors is a member of the FDA's Tobacco Products Scientific Advisory Committee, and could end up being involved in decision-making regarding electronic cigarette policy. This would be unfortunate because we need experts who are willing to consider the evidence rather than those who make pre-determined conclusions before the research has even been conducted.
Curiously, however, the article concludes - before any of the research that it calls for has been conducted - that the results of this research should be used "to counteract e-cigarette industry marketing."
The article concludes as follows: "The emergence of the e-cigarette industry must be met with an informed public health response. Research on product design, toxicant exposure, abuse liability including dual use with tobacco products, youth initiation, and influence on cessation efforts is needed to counteract e-cigarette industry marketing and inform regulatory strategies."
In other words, the authors are concluding that research is necessary to inform an appropriate public health response, but that regardless of what the research actually shows, its purpose is simply to provide evidence to counteract e-cigarette marketing: that is, to discourage electronic cigarette use.
Apparently, it doesn't matter what the research actually shows. The authors have apparently drawn a pre-determined conclusion that electronic cigarettes are harmful to the public health and therefore we should discourage people from using these products. But this conclusion precedes the research they call for to determine whether or not the product is safer than regular cigarettes, how effective it is in smoking cessation, and whether or not it encourages youth smoking initiation or dual use with tobacco products.
What then, is the point of the research?
The Rest of the Story
Apparently, the purpose of the research is to support a pre-determined conclusion that we should discourage people from using electronic cigarettes.
But what if the research were to show that electronic cigarettes are very effective in helping people quit smoking and that they are much safer than regular cigarettes (two hypotheses for which there is very strong preliminary evidence)?
I guess it wouldn't matter, because according to this article, we need the research "to counteract e-cigarette industry marketing."
Clearly, according to this article, there is no point in doing the research in the first place. If the pre-determined conclusion is that electronic cigarettes are evil and will harm the public's health, then why waste the money on the research? Why not just ban electronic cigarettes, here and now? Doing the research would actually be devastating to the public's health, as countless lives would be lost from toxicant exposure, dual use, youth initiation, and decreased cessation during the mean time.
On the other hand, if the research ends up confirming preliminary evidence that electronic cigarettes are much safer than regular ones and that they are very helpful to many vapers in keeping them off cigarettes, then efforts to counter electronic cigarette marketing will be contrary to the protection of the public's health, and will end up killing people. How is that a good thing? And why would you want to promote an action that might end up killing people before you have the facts in place?
An additional troubling aspect of this story is that one of the authors is a member of the FDA's Tobacco Products Scientific Advisory Committee, and could end up being involved in decision-making regarding electronic cigarette policy. This would be unfortunate because we need experts who are willing to consider the evidence rather than those who make pre-determined conclusions before the research has even been conducted.
Monday, October 25, 2010
Anti-Smoking Groups Telling Lies to the Public About Dangers of Secondhand Smoke
In an effort to over-dramatize the dangers of very brief exposure to secondhand smoke, a number of anti-smoking groups are telling lies to the public about the short-term cardiovascular effects of secondhand smoke.
Today, I highlight four of these groups and the lies they are disseminating to the public.
1. Kentucky Center for Smoke-Free Policy, University of Kentucky College of Nursing
According to a one-page "fact sheet" on secondhand smoke and heart disease, dated this year (2010):
"Even brief exposure to secondhand smoke can trigger a heart attack. ... In 20-30 minutes, fat and blood clots build up in the arteries, increasing the chance of heart attacks and stroke. After 2 hours of secondhand smoke exposure, the heart rate speeds up and leads to abnormal heart rhythms (which can lead to death)."
The "fact sheet" cites the 2001 Otsuka study published in JAMA to support these claims. However, the Otsuka study did not find that 30 minutes of secondhand smoke exposure results in a build up of fat and blood clots in the arteries, increasing the chance of heart attacks and strokes. Nor did it find that 2 hours of exposure caused abnormal heart rhythms which could lead to death.
In fact, both of these statements are outright lies. You don't get a build up of fat and blood clots in the arteries in just 30 minutes. What happens in 30 minutes is that the cells lining your coronary blood vessels do not function normally, leading to a reduction in coronary flow velocity reserve. This damage to the blood vessel lining is reversible. However, if repeated over and over again and sustained for many years, these effects could contribute to the formation of atherosclerosis (hardening of the arteries). But it is a lie to state that 30 minutes of tobacco smoke exposure results in a build up of fat and blood clots in the arteries that increases the chance of a heart attack or stroke.
It is also untrue that 2 hours of exposure to secondhand smoke causes potentially catastrophic cardiac arrhythmias. What short-term tobacco smoke exposure can do is reduce heart rate variability. This is an important finding in that it provides biologic plausibility for the finding of a relationship between chronic secondhand smoke exposure and heart disease, but it does not mean that an individual exposed to tobacco smoke for 2 hours is at increased risk of dying of a cardiac arrhythmia.
This claim actually relates to a study by Pope et al., not to the Otsuka study. See my previous post for a detailed discussion of this lie.
2. Florida Department of Health
According to a presentation posted online by the Florida Department of Health: "Non-smokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."
The study used to support this claim is also the Otsuka study. However, that study did not show that nonsmokers exposed to secondhand smoke for just 30 minutes experienced hardening of the arteries. It merely showed that they sustained vascular injury in terms of endothelial damage. The subjects in the Otsuka experiment certainly did not experience hardening of the arteries. The Institutional Review Board would never have approved such a study if there was even a possibility that the subjects would develop atherosclerotic heart disease as a result of the 30 minute tobacco smoke exposure.
Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.
3. Maricopa County Department of Public Health
According to a "fact sheet" disseminated by the Maricopa County Department of Public Health: "Nonsmokers exposed to secondhand smoke for just 30 minutes experience hardening of
the arteries."
Just as with the lie from the Florida Department of Health, the study used to support this claim is also the Otsuka study. However, once again, that study did not show that nonsmokers exposed to secondhand smoke for just 30 minutes experienced hardening of the arteries. It merely showed that they sustained vascular injury in terms of endothelial damage. The subjects in the Otsuka experiment certainly did not experience hardening of the arteries. The Institutional Review Board would never have approved such a study if there was even a possibility that the subjects would develop atherosclerotic heart disease as a result of the 30 minute tobacco smoke exposure.
Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.
4. Americans for Nonsmokers' Rights
According to a "fact sheet" being disseminated by Americans for Nonsmokers' Rights (ANR): "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."
This, too, is a lie. Nonsmokers exposed briefly to secondhand smoke do not suffer heart damage similar to that of habitual smokers. In fact, they do not suffer heart damage at all. Brief tobacco smoke exposure does not cause heart damage. What is does cause is endothelial damage (reversible vascular injury to the cells that line the coronary arteries). Heart damage refers to actual damage to the heart muscle, such as one sustains after myocardial ischemia or a heart attack.
Believe me, the subjects in the Otsuka experiment did not suffer heart damage. If they did, they could sue the university for causing this damage. The IRB would never approved the study if it was even thought that the tobacco smoke exposure might cause heart damage.
ANR is disseminating a lie that distorts the truth and makes brief tobacco smoke exposure sound much worse that it actually is. No, 30 minutes of smoke exposure is not going to cause heart damage. However, it may cause vascular damage to the endothelium that - if repeated and sustained over a long period of time, could eventually lead to atherosclerosis.
There is, in fact, no evidence that 30 minutes of secondhand smoke causes any heart damage. Does it impair the function of the cells lining the coronary arteries? Yes. But does that cause heart damage? No. Not from just 30 minutes of exposure.
If sustained over many years, the endothelial dysfunction caused by tobacco smoke exposure could result in atherosclerosis. However, this is not going to occur from a 30-minute exposure. So it is massively deceptive to suggest that a 30 minute exposure causes heart damage, much less that it causes heart damage that is similar to that observed in long-term active smokers, who may have developed severe coronary artery stenosis and suffered heart attacks which destroyed heart muscle.
This claim is not only untruthful, but it undermines the public's appreciation of the very real hazards of active smoking. If the public were to take ANR at its word, they would believe that smoking causes heart damage only as bad as a brief secondhand smoke exposure. Obviously, this is not true. The heart damage caused by chronic active smoking can be severe and even fatal. But there is no heart damage from a mere 30 minutes of exposure.
Given the real scientific evidence about the hazardous effects of secondhand smoke exposure, including the development of heart disease among individuals with chronic secondhand smoke exposure, why does ANR need to resort to a lie?
The Rest of the Story
The shame in all of these lies is that they are completely unnecessary. Isn't the truth enough? Shouldn't we be able to convince policy makers to protect nonsmokers from exposure to secondhand smoke by relying upon the proven health risks of chronic secondhand smoke exposure? We don't need to tell lies in order to advance sound public policies which protect nonsmokers from secondhand smoke exposure. The truth is enough.
Beyond the ethical considerations in spreading lies to the public, there are two additional considerations. First, these lies threaten to destroy the credibility of anti-smoking groups. If the public believes that we are lying about some aspects of secondhand smoke, then the public may likely dismiss everything we say, even our other statements which are true. Second, by exaggerating the effects of short-term secondhand smoke exposure and declaring that such effects are equivalent to those from active smoking, we may actually be undermining the public's appreciation of the hazards of smoking itself. We are also distorting the public's appreciation of the relationship between dose and response. Why should a smoker quit smoking if he believes that just 30 minutes of secondhand smoke exposure will cause the same amount of heart damage that he has sustained over his lifetime?
I would like to think that what distinguishes the tobacco control movement from the tobacco industry is that we tell the truth and do not tell lies to the public. Apparently, this is not always the case. Unless someone acts quickly to clean up what is passing for science among tobacco control organizations, we will not be able to hold on to our contention that we in tobacco control tell only the truth. Like so many other social movements, it appears that we, too, are lying to the public in ways that exaggerate and distort the actual science.
Today, I highlight four of these groups and the lies they are disseminating to the public.
1. Kentucky Center for Smoke-Free Policy, University of Kentucky College of Nursing
According to a one-page "fact sheet" on secondhand smoke and heart disease, dated this year (2010):
"Even brief exposure to secondhand smoke can trigger a heart attack. ... In 20-30 minutes, fat and blood clots build up in the arteries, increasing the chance of heart attacks and stroke. After 2 hours of secondhand smoke exposure, the heart rate speeds up and leads to abnormal heart rhythms (which can lead to death)."
The "fact sheet" cites the 2001 Otsuka study published in JAMA to support these claims. However, the Otsuka study did not find that 30 minutes of secondhand smoke exposure results in a build up of fat and blood clots in the arteries, increasing the chance of heart attacks and strokes. Nor did it find that 2 hours of exposure caused abnormal heart rhythms which could lead to death.
In fact, both of these statements are outright lies. You don't get a build up of fat and blood clots in the arteries in just 30 minutes. What happens in 30 minutes is that the cells lining your coronary blood vessels do not function normally, leading to a reduction in coronary flow velocity reserve. This damage to the blood vessel lining is reversible. However, if repeated over and over again and sustained for many years, these effects could contribute to the formation of atherosclerosis (hardening of the arteries). But it is a lie to state that 30 minutes of tobacco smoke exposure results in a build up of fat and blood clots in the arteries that increases the chance of a heart attack or stroke.
It is also untrue that 2 hours of exposure to secondhand smoke causes potentially catastrophic cardiac arrhythmias. What short-term tobacco smoke exposure can do is reduce heart rate variability. This is an important finding in that it provides biologic plausibility for the finding of a relationship between chronic secondhand smoke exposure and heart disease, but it does not mean that an individual exposed to tobacco smoke for 2 hours is at increased risk of dying of a cardiac arrhythmia.
This claim actually relates to a study by Pope et al., not to the Otsuka study. See my previous post for a detailed discussion of this lie.
2. Florida Department of Health
According to a presentation posted online by the Florida Department of Health: "Non-smokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."
The study used to support this claim is also the Otsuka study. However, that study did not show that nonsmokers exposed to secondhand smoke for just 30 minutes experienced hardening of the arteries. It merely showed that they sustained vascular injury in terms of endothelial damage. The subjects in the Otsuka experiment certainly did not experience hardening of the arteries. The Institutional Review Board would never have approved such a study if there was even a possibility that the subjects would develop atherosclerotic heart disease as a result of the 30 minute tobacco smoke exposure.
Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.
3. Maricopa County Department of Public Health
According to a "fact sheet" disseminated by the Maricopa County Department of Public Health: "Nonsmokers exposed to secondhand smoke for just 30 minutes experience hardening of
the arteries."
Just as with the lie from the Florida Department of Health, the study used to support this claim is also the Otsuka study. However, once again, that study did not show that nonsmokers exposed to secondhand smoke for just 30 minutes experienced hardening of the arteries. It merely showed that they sustained vascular injury in terms of endothelial damage. The subjects in the Otsuka experiment certainly did not experience hardening of the arteries. The Institutional Review Board would never have approved such a study if there was even a possibility that the subjects would develop atherosclerotic heart disease as a result of the 30 minute tobacco smoke exposure.
Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.
4. Americans for Nonsmokers' Rights
According to a "fact sheet" being disseminated by Americans for Nonsmokers' Rights (ANR): "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."
This, too, is a lie. Nonsmokers exposed briefly to secondhand smoke do not suffer heart damage similar to that of habitual smokers. In fact, they do not suffer heart damage at all. Brief tobacco smoke exposure does not cause heart damage. What is does cause is endothelial damage (reversible vascular injury to the cells that line the coronary arteries). Heart damage refers to actual damage to the heart muscle, such as one sustains after myocardial ischemia or a heart attack.
Believe me, the subjects in the Otsuka experiment did not suffer heart damage. If they did, they could sue the university for causing this damage. The IRB would never approved the study if it was even thought that the tobacco smoke exposure might cause heart damage.
ANR is disseminating a lie that distorts the truth and makes brief tobacco smoke exposure sound much worse that it actually is. No, 30 minutes of smoke exposure is not going to cause heart damage. However, it may cause vascular damage to the endothelium that - if repeated and sustained over a long period of time, could eventually lead to atherosclerosis.
There is, in fact, no evidence that 30 minutes of secondhand smoke causes any heart damage. Does it impair the function of the cells lining the coronary arteries? Yes. But does that cause heart damage? No. Not from just 30 minutes of exposure.
If sustained over many years, the endothelial dysfunction caused by tobacco smoke exposure could result in atherosclerosis. However, this is not going to occur from a 30-minute exposure. So it is massively deceptive to suggest that a 30 minute exposure causes heart damage, much less that it causes heart damage that is similar to that observed in long-term active smokers, who may have developed severe coronary artery stenosis and suffered heart attacks which destroyed heart muscle.
This claim is not only untruthful, but it undermines the public's appreciation of the very real hazards of active smoking. If the public were to take ANR at its word, they would believe that smoking causes heart damage only as bad as a brief secondhand smoke exposure. Obviously, this is not true. The heart damage caused by chronic active smoking can be severe and even fatal. But there is no heart damage from a mere 30 minutes of exposure.
Given the real scientific evidence about the hazardous effects of secondhand smoke exposure, including the development of heart disease among individuals with chronic secondhand smoke exposure, why does ANR need to resort to a lie?
The Rest of the Story
The shame in all of these lies is that they are completely unnecessary. Isn't the truth enough? Shouldn't we be able to convince policy makers to protect nonsmokers from exposure to secondhand smoke by relying upon the proven health risks of chronic secondhand smoke exposure? We don't need to tell lies in order to advance sound public policies which protect nonsmokers from secondhand smoke exposure. The truth is enough.
Beyond the ethical considerations in spreading lies to the public, there are two additional considerations. First, these lies threaten to destroy the credibility of anti-smoking groups. If the public believes that we are lying about some aspects of secondhand smoke, then the public may likely dismiss everything we say, even our other statements which are true. Second, by exaggerating the effects of short-term secondhand smoke exposure and declaring that such effects are equivalent to those from active smoking, we may actually be undermining the public's appreciation of the hazards of smoking itself. We are also distorting the public's appreciation of the relationship between dose and response. Why should a smoker quit smoking if he believes that just 30 minutes of secondhand smoke exposure will cause the same amount of heart damage that he has sustained over his lifetime?
I would like to think that what distinguishes the tobacco control movement from the tobacco industry is that we tell the truth and do not tell lies to the public. Apparently, this is not always the case. Unless someone acts quickly to clean up what is passing for science among tobacco control organizations, we will not be able to hold on to our contention that we in tobacco control tell only the truth. Like so many other social movements, it appears that we, too, are lying to the public in ways that exaggerate and distort the actual science.
Thursday, October 21, 2010
Action on Smoking and Health Reinforces Its Claim that 30 Minutes of Smoke Exposure Raises a Nonsmokers' Fatal Heart Attack Risk to That of a Smoker
This is a tale of two organizations. When it was pointed out to Americans for Nonsmokers' Rights (ANR) that its web site contained a hysterical claim about the dangers of smokers' clothing that was based solely on a press release from a textile institute, ANR promptly removed the material from its web site. In contrast, when it was pointed out to Action on Smoking and Health (ASH) that its even more hysterical claim was false, ASH didn't remove the claim. Instead, it reiterated, reinforced, and strengthened the claim.
Today, ASH is claiming that: "even 30 minutes of exposure to small amounts of drifting secondhand tobacco smoke can increase a nonsmokers' risk of a heart attack to that of a smoker, and can trigger a (sometimes fatal) heart attack."
It has moved this claim from one of many claims made on a web page to a page of its own, giving it special prominence.
The Rest of the Story
To see how obviously false this claim is, simply reverse it. What ASH is stating is that a smoker's risk of a fatal heart attack is no higher than if he never smoked in his life but merely was exposed to secondhand smoke for 30 minutes.
Obviously, that is false.
In fact, I would say that the claim is severely damaging, because it truly undermines the public's appreciation of the very real and severe cardiovascular hazards of smoking. If the public believes what ASH is saying, then they will believe that active smoking puts them at no higher a level of risk for a fatal heart attack than breathing drifting tobacco smoke for 30 minutes. Such a belief could have tragic consequences, as it would undermine public health messages that we have been sending out for the past five decades.
ASH's claim also undermines the importance of the dose-response relationship between cigarette smoke exposure and heart attack risk. If it is true that a smoker's risk of a heart attack is no higher than someone who walks into a smoky rib shack for 30 minutes one time, then smoking for 40 years doesn't put you at any increased heart attack risk as smoking for 20 years, or for 1 year for that matter. Smoking 4 packs a day isn't any worse than smoking a few cigarettes a day. And most devastatingly, quitting smoking apparently will not reduce your heart attack risk at all if you still hang out with your smoking friends for a half hour on occasion. So why quit smoking?
ASH's claim is based on a number of studies, especially one by Otsuka et al., which found that 30 minutes of secondhand smoke exposure produces endothelial dysfunction in nonsmokers, and reduces their coronary flow velocity reserve to the same level as that in smokers. However, there is a critical difference between the finding of reduced coronary flow velocity reserve and the finding of an increased heart attack risk. In fact, having reduced coronary flow velocity reserve does not equate to being at an increased risk of a heart attack. In the healthy volunteers who were studied by Otsuka et al., there was no increased heart attack risk faced by these patients. Had there been such a risk, then the study would have been unethical and it never would have been approved by an institutional review board. Certainly, the subjects would have had to be warned that they would face an increased risk of heart attack and possibly death.
Moreover, eating a hamburger reduces coronary flow velocity reserve to roughly the same extent as in an active smoker. Would it therefore be accurate for ASH to claim that "eating a single hamburger can increase a person's risk of a heart attack to that of a smoker?" Of course not. If you walk into McDonald's and order a hamburger, you may be at risk of disease, but not from immediately keeling over from a heart attack.
Luckily, the tobacco companies are a little more honest than ASH is being here, and they have not taken this opportunity to claim publicly that: "Smoking puts you at no more risk of a heart attack than eating a single hamburger." Based on ASH's statement, the tobacco companies could accurately make such a claim. The tobacco companies aren't misrepresenting the science about this. Why is ASH?
Today, ASH is claiming that: "even 30 minutes of exposure to small amounts of drifting secondhand tobacco smoke can increase a nonsmokers' risk of a heart attack to that of a smoker, and can trigger a (sometimes fatal) heart attack."
It has moved this claim from one of many claims made on a web page to a page of its own, giving it special prominence.
The Rest of the Story
To see how obviously false this claim is, simply reverse it. What ASH is stating is that a smoker's risk of a fatal heart attack is no higher than if he never smoked in his life but merely was exposed to secondhand smoke for 30 minutes.
Obviously, that is false.
In fact, I would say that the claim is severely damaging, because it truly undermines the public's appreciation of the very real and severe cardiovascular hazards of smoking. If the public believes what ASH is saying, then they will believe that active smoking puts them at no higher a level of risk for a fatal heart attack than breathing drifting tobacco smoke for 30 minutes. Such a belief could have tragic consequences, as it would undermine public health messages that we have been sending out for the past five decades.
ASH's claim also undermines the importance of the dose-response relationship between cigarette smoke exposure and heart attack risk. If it is true that a smoker's risk of a heart attack is no higher than someone who walks into a smoky rib shack for 30 minutes one time, then smoking for 40 years doesn't put you at any increased heart attack risk as smoking for 20 years, or for 1 year for that matter. Smoking 4 packs a day isn't any worse than smoking a few cigarettes a day. And most devastatingly, quitting smoking apparently will not reduce your heart attack risk at all if you still hang out with your smoking friends for a half hour on occasion. So why quit smoking?
ASH's claim is based on a number of studies, especially one by Otsuka et al., which found that 30 minutes of secondhand smoke exposure produces endothelial dysfunction in nonsmokers, and reduces their coronary flow velocity reserve to the same level as that in smokers. However, there is a critical difference between the finding of reduced coronary flow velocity reserve and the finding of an increased heart attack risk. In fact, having reduced coronary flow velocity reserve does not equate to being at an increased risk of a heart attack. In the healthy volunteers who were studied by Otsuka et al., there was no increased heart attack risk faced by these patients. Had there been such a risk, then the study would have been unethical and it never would have been approved by an institutional review board. Certainly, the subjects would have had to be warned that they would face an increased risk of heart attack and possibly death.
Moreover, eating a hamburger reduces coronary flow velocity reserve to roughly the same extent as in an active smoker. Would it therefore be accurate for ASH to claim that "eating a single hamburger can increase a person's risk of a heart attack to that of a smoker?" Of course not. If you walk into McDonald's and order a hamburger, you may be at risk of disease, but not from immediately keeling over from a heart attack.
Luckily, the tobacco companies are a little more honest than ASH is being here, and they have not taken this opportunity to claim publicly that: "Smoking puts you at no more risk of a heart attack than eating a single hamburger." Based on ASH's statement, the tobacco companies could accurately make such a claim. The tobacco companies aren't misrepresenting the science about this. Why is ASH?
Wednesday, October 20, 2010
At Home and Abroad, Facts About Electronic Cigarettes are Grossly Misrepresented by Health Experts
The facts about electronic cigarettes continue to be grossly distorted and misrepresented by health experts in order to scare people about the potential risks of vaping, a dishonest communication that is likely to cause harm by convincing many vapers to return to cigarette smoking or dissuading smokers who could likely quit by using electronic cigarettes and causing them to continue smoking instead.
At Home
In an interview on Atlanta's Fox5 News yesterday, Dr. Carla Berg from Emory's Rollins School of Public Health made two factual misstatements in what amounted to a distortion of the scientific evidence regarding the relative health risks of smoking compared to vaping.
First, Dr. Berg stated that electronic cigarettes contain a component in anti-freeze (referring to diethylene glycol), implying that all electronic cigarettes are contaminated with diethylene glycol.
This statement is untrue. Diethylene glycol has only been detected in one cartridge of one brand of electronic cigarettes. Multiple other brands of electronic cigarettes have undergone testing and have been found not to contain diethylene glycol.
On national television, one would hope that health experts would at very least provide accurate information. The claim that all electronic cigarettes are contaminated with diethylene glycol is simply untrue, and it reflects an apparent failure of the expert to review the multiple studies (at least 12 are easily available online) in which gas chromatographic mass spectrometric analysis of a variety of brands of electronic cigarettes have failed to detect diethylene glycol.
Second, Dr. Berg stated that one only sees flavors used in electronic cigarettes, but never in nicotine replacement products approved by the FDA.
This is also untrue. For example, Nicorette lozenges come in kid-friendly cherry and mint flavors. Nicorette gum comes in a Fruit Chill flavor. Habitrol comes in a mint flavor. Other nicotine replacement product flavors that are being marketed include White Ice Mint, fruit, Good Sense mint, Cool Mint, and Cinnamon Surge.
Health experts are entitled to make the argument that unlike NRT products, electronic cigarettes are being marketed to children; however, they need to base their arguments on evidence that is true, not made up.
When you start seeing people concoct false evidence to support their premises, that's when you should become suspicious that the arguments underlying their positions are incredibly weak.
In fact, in the interview, Dr. Berg refused to admit that electronic cigarettes are safer than regular cigarettes. She appeared to be blinded by some sort of ideological dogma and to be grasping to support her position by making statements that are demonstrably false.
Abroad
In an article in the Malay Mail, Malaysia's deputy health minister is quoted as stating that vaping is "just as bad" as smoking. According to the article, the health ministry does not believe that active smoking of Marlboro or other carcinogen-laden cigarettes is any worse than vaping -- a behavior that involves inhaling vapor from a product containing no tobacco whatsoever and which has been documented by the FDA itself to contain only trace levels of carcinogens.
In addition, the health ministry stated that electronic cigarettes are not used to help smokers quit. There is absolutely no evidence to support this claim, and overwhelming anecdotal and survey evidence support just the opposite: that many vapers are successfully using electronic cigarettes to stay off the real ones.
The deputy health minister stated: "There is concern this nicotine delivery to the human lung might result in stronger toxicological, physiological and addictive effects, and this must be addressed in scientific studies."
Fine. But if that's the case, then why isn't the deputy health minister also calling for the removal of the nicotine inhaler from the market? After all, if it is unsafe to market a product which delivers nicotine to the lung, then shouldn't nicotine inhalers be removed from the market immediately, pending further studies to examine the toxicological, physiological, and addictive effects of the lung delivery of nicotine?
In both cases, these uninformed, misleading, and in some cases false statements are doing significant public health harm by convincing many ex-smokers to return to smoking because of undue fears about the hazards of the electronic cigarettes they have been using to successfully keep them off regular cigarettes.
At Home
In an interview on Atlanta's Fox5 News yesterday, Dr. Carla Berg from Emory's Rollins School of Public Health made two factual misstatements in what amounted to a distortion of the scientific evidence regarding the relative health risks of smoking compared to vaping.
First, Dr. Berg stated that electronic cigarettes contain a component in anti-freeze (referring to diethylene glycol), implying that all electronic cigarettes are contaminated with diethylene glycol.
This statement is untrue. Diethylene glycol has only been detected in one cartridge of one brand of electronic cigarettes. Multiple other brands of electronic cigarettes have undergone testing and have been found not to contain diethylene glycol.
On national television, one would hope that health experts would at very least provide accurate information. The claim that all electronic cigarettes are contaminated with diethylene glycol is simply untrue, and it reflects an apparent failure of the expert to review the multiple studies (at least 12 are easily available online) in which gas chromatographic mass spectrometric analysis of a variety of brands of electronic cigarettes have failed to detect diethylene glycol.
Second, Dr. Berg stated that one only sees flavors used in electronic cigarettes, but never in nicotine replacement products approved by the FDA.
This is also untrue. For example, Nicorette lozenges come in kid-friendly cherry and mint flavors. Nicorette gum comes in a Fruit Chill flavor. Habitrol comes in a mint flavor. Other nicotine replacement product flavors that are being marketed include White Ice Mint, fruit, Good Sense mint, Cool Mint, and Cinnamon Surge.
Health experts are entitled to make the argument that unlike NRT products, electronic cigarettes are being marketed to children; however, they need to base their arguments on evidence that is true, not made up.
When you start seeing people concoct false evidence to support their premises, that's when you should become suspicious that the arguments underlying their positions are incredibly weak.
In fact, in the interview, Dr. Berg refused to admit that electronic cigarettes are safer than regular cigarettes. She appeared to be blinded by some sort of ideological dogma and to be grasping to support her position by making statements that are demonstrably false.
Abroad
In an article in the Malay Mail, Malaysia's deputy health minister is quoted as stating that vaping is "just as bad" as smoking. According to the article, the health ministry does not believe that active smoking of Marlboro or other carcinogen-laden cigarettes is any worse than vaping -- a behavior that involves inhaling vapor from a product containing no tobacco whatsoever and which has been documented by the FDA itself to contain only trace levels of carcinogens.
In addition, the health ministry stated that electronic cigarettes are not used to help smokers quit. There is absolutely no evidence to support this claim, and overwhelming anecdotal and survey evidence support just the opposite: that many vapers are successfully using electronic cigarettes to stay off the real ones.
The deputy health minister stated: "There is concern this nicotine delivery to the human lung might result in stronger toxicological, physiological and addictive effects, and this must be addressed in scientific studies."
Fine. But if that's the case, then why isn't the deputy health minister also calling for the removal of the nicotine inhaler from the market? After all, if it is unsafe to market a product which delivers nicotine to the lung, then shouldn't nicotine inhalers be removed from the market immediately, pending further studies to examine the toxicological, physiological, and addictive effects of the lung delivery of nicotine?
In both cases, these uninformed, misleading, and in some cases false statements are doing significant public health harm by convincing many ex-smokers to return to smoking because of undue fears about the hazards of the electronic cigarettes they have been using to successfully keep them off regular cigarettes.
Tuesday, October 19, 2010
ANR Removes Unsupported Thirdhand Smoke Claim from Web Site
Presumably in response to my commentaries pointing out the lack of scientific support for the claim that touching a smoker's clothing can cause massive skin and neurological injury to children, Americans for Nonsmokers' Rights (ANR) has removed from its web site all references to this claim, which was originally made by Action on Smoking and Health (ASH) and based on a gross exaggeration of a press release by a textile institution (original ANR web page; current ANR web page).
I congratulate ANR on having the scientific integrity to remove this unsupported claim from its web site. I hope that ASH will also follow suit.
As I explained yesterday, the rigor of our scientific review of claims that we make is critical because if we make exaggerated claims in one area (e.g., thirdhand smoke), it will affect the public's perception of our credibility in making claims in another area (e.g., secondhand smoke or even active smoking). We don't want the public to throw away the baby with the bath water. But that's exactly what people will do once we lose the public's trust. People are not going to discriminate between the accurate claims and those which are exaggerated or untrue. They will simply discount everything that we say.
We saw an excellent example of this in the swine flu scare last year, when exaggerated claims made by health groups led to massive disregard for the very serious and real - but far less hysterical - risks posed by swine flu. As a result, vaccination rates were dismal for the swine flu vaccine. This led to needless morbidity and even mortality. It was a real life example of how loss of the public's trust due to exaggerated health claims can lead to a public health disaster.
The Rest of the Story
Now that ANR has removed the unsupported claim that merely touching a smoker's clothing can cause massive skin and neurological damage, I hope that it reviews and removes its equally hysterical and unsupported claim that 30 minutes of secondhand smoke exposure causes heart damage similar to that caused by chronic active smokers and that 30 minutes of exposure reduces the ability of the heart to get life-giving blood.
The claim that ANR makes is as follows: "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers. Nonsmokers’ heart arteries showed a reduced ability to dilate, diminishing the ability of the heart to get life-giving blood."
ANR has grossly exaggerated the results of the Otsuka et al. study so much that they turned an important scientific finding into a blatant misrepresentation of the truth.
It is not true that 30 minutes of secondhand smoke exposure causes any heart damage, much less damage that is similar to that sustained after many years of active smoking. It is also not true that the hearts of nonsmokers exposed to secondhand smoke for 30 minutes are impaired in their ability to get life-giving blood.
In fact, the Otsuka et al. study, which is the one being relied upon for this statement, actually demonstrated that there is no impairment of basal coronary artery blood flow in subjects exposed to high levels of secondhand smoke for 30 minutes. The study itself documents that there was not any reduced ability of the heart to get life-giving blood!
Thus, the statement is contradicted by the very study which ANR claims supports it.
There is, in fact, no evidence that 30 minutes of secondhand smoke causes any heart damage. Does it impair the function of the cells lining the coronary arteries? Yes. But does that cause heart damage? No. Not from just 30 minutes of exposure.
If sustained over many years, the endothelial dysfunction caused by tobacco smoke exposure could result in atherosclerosis. However, this is not going to occur from a 30-minute exposure. So it is massively deceptive to suggest that a 30 minute exposure causes heart damage, much less that it causes heart damage that is similar to that observed in long-term active smokers, who may have developed severe coronary artery stenosis and suffered heart attacks which destroyed heart muscle.
Given the real scientific evidence about the hazardous effects of secondhand smoke exposure, including the development of heart disease among individuals with chronic secondhand smoke exposure, why does ANR need to exaggerate and distort the truth?
I congratulate ANR on having the scientific integrity to remove this unsupported claim from its web site. I hope that ASH will also follow suit.
As I explained yesterday, the rigor of our scientific review of claims that we make is critical because if we make exaggerated claims in one area (e.g., thirdhand smoke), it will affect the public's perception of our credibility in making claims in another area (e.g., secondhand smoke or even active smoking). We don't want the public to throw away the baby with the bath water. But that's exactly what people will do once we lose the public's trust. People are not going to discriminate between the accurate claims and those which are exaggerated or untrue. They will simply discount everything that we say.
We saw an excellent example of this in the swine flu scare last year, when exaggerated claims made by health groups led to massive disregard for the very serious and real - but far less hysterical - risks posed by swine flu. As a result, vaccination rates were dismal for the swine flu vaccine. This led to needless morbidity and even mortality. It was a real life example of how loss of the public's trust due to exaggerated health claims can lead to a public health disaster.
The Rest of the Story
Now that ANR has removed the unsupported claim that merely touching a smoker's clothing can cause massive skin and neurological damage, I hope that it reviews and removes its equally hysterical and unsupported claim that 30 minutes of secondhand smoke exposure causes heart damage similar to that caused by chronic active smokers and that 30 minutes of exposure reduces the ability of the heart to get life-giving blood.
The claim that ANR makes is as follows: "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers. Nonsmokers’ heart arteries showed a reduced ability to dilate, diminishing the ability of the heart to get life-giving blood."
ANR has grossly exaggerated the results of the Otsuka et al. study so much that they turned an important scientific finding into a blatant misrepresentation of the truth.
It is not true that 30 minutes of secondhand smoke exposure causes any heart damage, much less damage that is similar to that sustained after many years of active smoking. It is also not true that the hearts of nonsmokers exposed to secondhand smoke for 30 minutes are impaired in their ability to get life-giving blood.
In fact, the Otsuka et al. study, which is the one being relied upon for this statement, actually demonstrated that there is no impairment of basal coronary artery blood flow in subjects exposed to high levels of secondhand smoke for 30 minutes. The study itself documents that there was not any reduced ability of the heart to get life-giving blood!
Thus, the statement is contradicted by the very study which ANR claims supports it.
There is, in fact, no evidence that 30 minutes of secondhand smoke causes any heart damage. Does it impair the function of the cells lining the coronary arteries? Yes. But does that cause heart damage? No. Not from just 30 minutes of exposure.
If sustained over many years, the endothelial dysfunction caused by tobacco smoke exposure could result in atherosclerosis. However, this is not going to occur from a 30-minute exposure. So it is massively deceptive to suggest that a 30 minute exposure causes heart damage, much less that it causes heart damage that is similar to that observed in long-term active smokers, who may have developed severe coronary artery stenosis and suffered heart attacks which destroyed heart muscle.
Given the real scientific evidence about the hazardous effects of secondhand smoke exposure, including the development of heart disease among individuals with chronic secondhand smoke exposure, why does ANR need to exaggerate and distort the truth?
Sunday, October 17, 2010
Americans for Nonsmokers' Rights Reporting as "Science" Claims from Press Release by Institute that Markets Floor Mops
The anti-smoking group Americans for Nonsmokers' Rights (ANR) is passing off as "science" exaggerated and inaccurate claims made by another anti-smoking group (ASH) that are based solely on a press release issued by an institute that markets floor mops.
As a professor, I see all sorts of poor references for statements made in students' papers. However, I don't think I've yet seen anything as shoddy as what ANR is doing. On its information page related to thirdhand smoke, ANR has reported the wildly exaggerated and inaccurate claim by ASH that merely touching a smoker's clothes causes massive skin and nerve damage to young children.
I can't tell you how many times I have been working in the emergency room and seen a young child brought in with severe skin injury, and I asked the parents what caused it and they responded: "I am a smoker and little Johnny accidentally touched my shirt."
Even setting aside the gross exaggeration of the actual press release, relying upon just a press release, without examining the underlying study, is negligent. And in this case, it's even worse scientific negligence because there is no underlying study available to scrutinize and the press release comes not from an academic institution, but from an institute that studies and markets various forms of textiles, including new improved floor mops.
The entire point of the study in the first place was to develop evidence that could be used to scare parents who smoke about the potential hazards of their children touching their clothing so that they would buy special protective clothing that purportedly neutralizes any toxins in the clothing. This is hardly an objective scientific study to begin with.
But even more importantly, the study did not demonstrate or even examine actual clinical effects of touching the clothes of a smoker.
The Rest of the Story
This story shows how much tobacco control science has deteriorated. During the years during which I served on the Executive Board of ANR, we would never have disseminated information from a press release issued by a floor mop company.
Instead, we would have carefully scrutinized the actual study to make sure that the evidence was solid before reporting it to the public.
One possible reason for the deterioration of the scientific rigor of the movement is that the tobacco industry is no longer holding anti-smoking groups accountable for their statements. Back in the 1990s, we knew that if we made a statement to the public, the tobacco industry would scrutinize it and challenge it publicly if there were any weaknesses in the scientific support for the claim. That is no longer true, as the industry apparently made a decision (at some point around 2000 or 2001) to no longer monitor and challenge anti-smoking groups' claims. Left to their own devices, these groups are now willing to report anything, even if there is no scientific basis for the claim.
It's difficult for me now to understand the point of my research on secondhand smoke. If we are going to go ahead and report ridiculous claims - such as the idea that touching a smoker's clothes can lead to massive skin and nerve damage - without any scientific support other than a press release from a mop company, then what reason is there for me to continue to study the health effects of secondhand smoke, or thirdhand smoke for that matter? Why is research necessary if we are going to say anything we want about the health effects of secondhand and thirdhand smoke? What would be the point of the research?
Please understand that I agree with the majority of the information that ANR disseminates about the very real hazards of secondhand smoke. But even if just a few claims that ANR makes are hysterical - such as the extreme dangers of touching a smoker's clothing - the public may very well dismiss everything that ANR says, even the claims that are well-supported by scientific evidence.
If, to educate the public about thirdhand smoke, ANR is willing to rely upon a press release - in the absence of any published study - from a mop company, then why should the public have any faith that ANR is reporting the scientific evidence on secondhand smoke accurately?
What makes this problem most damaging is the fact that these groups will not retract or correct their claims, even after the lack of scientific support is pointed out to them. I have already informed ANR about the lack of scientific support for the "dangerous clothing" claim, but they still have the claim up on the web site. And ASH will likely respond not by retracting the claim, but by reiterating it.
It is one thing to make a mistake because of carelessness or errant interpretation of a technical study, but it is another to refuse to correct the claim after the mistake is pointed out. I wouldn't have such a problem with what these groups are doing if they were willing to update their web sites and to correct the information. But they have developed this stubbornness where they refuse to acknowledge that they ever make a mistake.
I acknowledge that I've made a lot of mistakes. But when they are pointed out, I correct them immediately. Why don't these anti-smoking groups do the same?
As a professor, I see all sorts of poor references for statements made in students' papers. However, I don't think I've yet seen anything as shoddy as what ANR is doing. On its information page related to thirdhand smoke, ANR has reported the wildly exaggerated and inaccurate claim by ASH that merely touching a smoker's clothes causes massive skin and nerve damage to young children.
I can't tell you how many times I have been working in the emergency room and seen a young child brought in with severe skin injury, and I asked the parents what caused it and they responded: "I am a smoker and little Johnny accidentally touched my shirt."
Even setting aside the gross exaggeration of the actual press release, relying upon just a press release, without examining the underlying study, is negligent. And in this case, it's even worse scientific negligence because there is no underlying study available to scrutinize and the press release comes not from an academic institution, but from an institute that studies and markets various forms of textiles, including new improved floor mops.
The entire point of the study in the first place was to develop evidence that could be used to scare parents who smoke about the potential hazards of their children touching their clothing so that they would buy special protective clothing that purportedly neutralizes any toxins in the clothing. This is hardly an objective scientific study to begin with.
But even more importantly, the study did not demonstrate or even examine actual clinical effects of touching the clothes of a smoker.
The Rest of the Story
This story shows how much tobacco control science has deteriorated. During the years during which I served on the Executive Board of ANR, we would never have disseminated information from a press release issued by a floor mop company.
Instead, we would have carefully scrutinized the actual study to make sure that the evidence was solid before reporting it to the public.
One possible reason for the deterioration of the scientific rigor of the movement is that the tobacco industry is no longer holding anti-smoking groups accountable for their statements. Back in the 1990s, we knew that if we made a statement to the public, the tobacco industry would scrutinize it and challenge it publicly if there were any weaknesses in the scientific support for the claim. That is no longer true, as the industry apparently made a decision (at some point around 2000 or 2001) to no longer monitor and challenge anti-smoking groups' claims. Left to their own devices, these groups are now willing to report anything, even if there is no scientific basis for the claim.
It's difficult for me now to understand the point of my research on secondhand smoke. If we are going to go ahead and report ridiculous claims - such as the idea that touching a smoker's clothes can lead to massive skin and nerve damage - without any scientific support other than a press release from a mop company, then what reason is there for me to continue to study the health effects of secondhand smoke, or thirdhand smoke for that matter? Why is research necessary if we are going to say anything we want about the health effects of secondhand and thirdhand smoke? What would be the point of the research?
Please understand that I agree with the majority of the information that ANR disseminates about the very real hazards of secondhand smoke. But even if just a few claims that ANR makes are hysterical - such as the extreme dangers of touching a smoker's clothing - the public may very well dismiss everything that ANR says, even the claims that are well-supported by scientific evidence.
If, to educate the public about thirdhand smoke, ANR is willing to rely upon a press release - in the absence of any published study - from a mop company, then why should the public have any faith that ANR is reporting the scientific evidence on secondhand smoke accurately?
What makes this problem most damaging is the fact that these groups will not retract or correct their claims, even after the lack of scientific support is pointed out to them. I have already informed ANR about the lack of scientific support for the "dangerous clothing" claim, but they still have the claim up on the web site. And ASH will likely respond not by retracting the claim, but by reiterating it.
It is one thing to make a mistake because of carelessness or errant interpretation of a technical study, but it is another to refuse to correct the claim after the mistake is pointed out. I wouldn't have such a problem with what these groups are doing if they were willing to update their web sites and to correct the information. But they have developed this stubbornness where they refuse to acknowledge that they ever make a mistake.
I acknowledge that I've made a lot of mistakes. But when they are pointed out, I correct them immediately. Why don't these anti-smoking groups do the same?
Thursday, October 14, 2010
Stop and Think About This: Anti-Smoking Groups are Telling the Public that Touching a Smoker's Clothes Can Cause Massive Skin and Neurological Damage
My Warnings About the Degradation of the Scientific Integrity of the Tobacco Control Movement Have, Unfortunately, Come True
For the past eight years, I have been warning the tobacco control community about a gradual but steady decline in the scientific rigor of the movement. During the first three of those years, my warnings were internal and expressed through tobacco control list-serves, discussion groups, and other internal communications. For the past five years, I have written about this issue on The Rest of the Story.
Many of my colleagues in tobacco control have dismissed my warnings, telling me that I was being overly critical and that the scientific integrity of the movement was in no danger.
As we sit here today, two major tobacco control groups - Action on Smoking and Health (ASH) and Americans for Nonsmokers' Rights (ANR) are telling the public that simply touching a smoker's clothing is extremely dangerous and can cause massive skin and neurological damage to children.
Both organizations - on their web sites - have the following statement: "Parents who do not smoke in the presence of their children, including even those who smoke only outdoors, nevertheless put their children at serious risk of "massive damage" to both skin and nerve cells, since a neurotoxin in thirdhand tobacco smoke penetrates the child's skin, according to recent research in Germany." (ASH statement here; ANR statement here)
If readers stop and think about this for just a moment, they will realize that my warnings have indeed come true: the scientific rigor of the movement has deteriorated. So much so that we are now putting out communications to the public warning that simply touching a smoker's clothing can cause massive neurologic and skin damage to children.
Need I say more? The case appears to be closed.
The Rest of the Story
If we review how these claims are "supported," you will see what I mean in arguing that the scientific rigor of the tobacco control movement has deteriorated.
Upon which of the following do you think these claims are based:
(a) A meta-analysis of several peer-reviewed scientific studies demonstrating clinically significant skin and neurologic damage among children who have touched a smoker's clothing.
(b) A single, peer-reviewed, scientific study demonstrating clinically significant skin and neurologic damage among children who have touched a smoker's clothing.
(c) A single peer-reviewed scientific study demonstrating an effect of tobacco smoke residue on skin and nerve cells in a cell culture model.
(d) A study demonstrating an effect of tobacco smoke residue on skin and nerve cells in a cell culture model.
(e) A press release issued in conjunction with the publication of a study on the effect of smokers' clothing on skin and nerve cells.
(f) A press release issued in conjunction with a non-peer-reviewed study on the effect of smokers' clothing on skin and nerve cells.
(g) A press release by researchers at an academic institution, without any accompanying study.
(h) A press release by researchers at a textile institution, without any accompanying study.
(i) A press release, without any accompanying study, by researchers at a textile institution which aims to market, and profit from, the sale of protective clothing sold to parents who they are able to scare about the potential toxic effects to children of touching a smoker's clothing.
Sadly, the answer is:
I. A press release, without any accompanying study, by researchers at a textile institution which aims to market, and profit from, the sale of protective clothing sold to parents who they are able to scare about the potential toxic effects to children of touching a smoker's clothing.
Do you mean to tell me that Americans for Nonsmokers' Rights - the leading anti-smoking group dealing with the issue of secondhand smoke - is disseminating the claim that a child can suffer massive skin and nerve cell damage simply from touching a smoker's clothes, based solely on the results of a press release by a textile firm that is aiming to sell special protective clothes to parents alarmed about the potential effects of their kid touching their clothes?
Do you mean to tell me that before putting this claim up on its web site, ANR failed to scrutinize the story to find out whether there was an actual study that could be evaluated for its scientific value and merit?
Do you mean to tell me that before alarming the public with a hysterical claim which flies in the face of common sense, ANR failed to put forward even an iota of scientific judgment to evaluate whether there was any validity behind the claim?
The rest of the story, sadly, is that ANR blindly disseminated this claim without any scientific scrutiny whatsoever. The claim is based solely on a press release.
And that press release does not come from objective scientists, but from a crazy institution that is aiming to sell textiles that claim to neutralize the toxins in cigarette smoke and can be sold to hysterical parents who are worried that their kids might be harmed just by touching their clothes.
The same institution which is aiming to sell the protective clothing for smokers is today boasting about a new type of floor mop.
So the rest of the story, actually, is the following:
ANR and ASH are telling the public that touching a smoker's clothing can cause massive skin and nerve damage to children, based solely on a press release from an institution that markets floor mops.
Need I say more?
Wednesday, October 13, 2010
Health Group Tells Public that Tobacco Smoke Residue on Clothing is "Extremely Dangerous"
The Greenup County Health Department is telling the public that tobacco smoke residue left on smokers' clothing is "extremely dangerous" and that it can cause both skin and nerve damage.
According to the Greenup County Health Department: "Results from a new study in Germany revealed that tobacco smoke residue – also known as “thirdhand smoke” - left on clothes, hair and skin after smoking is extremely dangerous, capable of causing skin and nerve damage – especially in children."
The national anti-smoking group Americans for Nonsmokers' Rights (ANR) is also disseminating this alarmist claim about tobacco smoke residue on clothing, quoting from Action on Smoking and Health (ASH) in writing: "Parents who do not smoke in the presence of their children, including even those who smoke only outdoors, nevertheless put their children at serious risk of "massive damage" to both skin and nerve cells, since a neurotoxin in thirdhand tobacco smoke penetrates the child's skin, according to recent research in Germany."
These hysterical claims about the extreme dangers of smokers' clothing - which allegedly causes nerve damage in children - stem from an episode of "science by press release," in which researchers issued a press release making these alarmist claims without actually releasing the study so that the methods and actual results and their significance could be scrutinized.
This episode of science by press release, which was first discovered by Michael McFadden, quickly led to a press release by ASH in which it claimed that thirdhand smoke on smokers' clothing could cause "massive damage" to the nerves and skin of children.
The Greenup County Health Department, which is located in the northeast corner of Kentucky, has turned off commenting on its article so that no one can point out the fact that the claims the Department is making are completely unsupported by scientific evidence.
The Rest of the Story
What ASH, ANR, and the Greenup County Health Department are not telling the public is that the study from Germany only examined the effect of tobacco smoke residues on clothing in a cell culture model. In other words, no actual humans were tested and there was no demonstration that in actual life there is any clinically significant effect of residue from smokers' clothing on the skin or nerves of children.
I challenge ASH, ANR, and the Greenup County Health Department to identify one case of "massive damage" to the skin or nerves of a child attributable to his or her contact with the clothing of a smoker.
In my medical training, I treated many children with massive skin damage and nervous system damage, but not a single case was attributable to their having touched a smoker's clothing. I also treated many children who had touched a smoker's clothing, but none of them had massive skin and nerve damage.
While the study examines the effect of residues in a skin cell culture model, it does not demonstrate actual skin damage "in real life." Moreover, the neurotoxicity is only a theoretical concern: the study provides no evidence that actual neurological damage occurs as a result of having contact with the clothes of a smoker.
Unfortunately, this didn't stop ASH, ANR, or the Greenup County Health Department from spreading unsupported conclusions widely through the media.
The rest of the story is that groups like ASH and ANR have no interest in actual scientific accuracy or scientific rigor. They are merely interested in disseminating tabloid news that will support their pre-ordained policy agenda. While I agree with many aspects of that agenda (especially the prohibition of smoking in the workplace, including bars, restaurants, and casinos), I do not support the use of shoddy scientific evidence to support these policies.
I think we need to be beyond reproach in our scientific rigor; otherwise, we risk losing credibility with the public. If we are telling the public that merely by touching a smoker's clothing, a child may suffer extremely dangerous nervous system injury, then clearly we don't have any credibility. So then, what is the chance that the public will believe us when we actually tell the truth? It's like the Boy Who Cried Wolf. Once we lose public trust, we will lose credibility even when we are making statements that are well-supported by scientific evidence.
According to the Greenup County Health Department: "Results from a new study in Germany revealed that tobacco smoke residue – also known as “thirdhand smoke” - left on clothes, hair and skin after smoking is extremely dangerous, capable of causing skin and nerve damage – especially in children."
The national anti-smoking group Americans for Nonsmokers' Rights (ANR) is also disseminating this alarmist claim about tobacco smoke residue on clothing, quoting from Action on Smoking and Health (ASH) in writing: "Parents who do not smoke in the presence of their children, including even those who smoke only outdoors, nevertheless put their children at serious risk of "massive damage" to both skin and nerve cells, since a neurotoxin in thirdhand tobacco smoke penetrates the child's skin, according to recent research in Germany."
These hysterical claims about the extreme dangers of smokers' clothing - which allegedly causes nerve damage in children - stem from an episode of "science by press release," in which researchers issued a press release making these alarmist claims without actually releasing the study so that the methods and actual results and their significance could be scrutinized.
This episode of science by press release, which was first discovered by Michael McFadden, quickly led to a press release by ASH in which it claimed that thirdhand smoke on smokers' clothing could cause "massive damage" to the nerves and skin of children.
The Greenup County Health Department, which is located in the northeast corner of Kentucky, has turned off commenting on its article so that no one can point out the fact that the claims the Department is making are completely unsupported by scientific evidence.
The Rest of the Story
What ASH, ANR, and the Greenup County Health Department are not telling the public is that the study from Germany only examined the effect of tobacco smoke residues on clothing in a cell culture model. In other words, no actual humans were tested and there was no demonstration that in actual life there is any clinically significant effect of residue from smokers' clothing on the skin or nerves of children.
I challenge ASH, ANR, and the Greenup County Health Department to identify one case of "massive damage" to the skin or nerves of a child attributable to his or her contact with the clothing of a smoker.
In my medical training, I treated many children with massive skin damage and nervous system damage, but not a single case was attributable to their having touched a smoker's clothing. I also treated many children who had touched a smoker's clothing, but none of them had massive skin and nerve damage.
While the study examines the effect of residues in a skin cell culture model, it does not demonstrate actual skin damage "in real life." Moreover, the neurotoxicity is only a theoretical concern: the study provides no evidence that actual neurological damage occurs as a result of having contact with the clothes of a smoker.
Unfortunately, this didn't stop ASH, ANR, or the Greenup County Health Department from spreading unsupported conclusions widely through the media.
The rest of the story is that groups like ASH and ANR have no interest in actual scientific accuracy or scientific rigor. They are merely interested in disseminating tabloid news that will support their pre-ordained policy agenda. While I agree with many aspects of that agenda (especially the prohibition of smoking in the workplace, including bars, restaurants, and casinos), I do not support the use of shoddy scientific evidence to support these policies.
I think we need to be beyond reproach in our scientific rigor; otherwise, we risk losing credibility with the public. If we are telling the public that merely by touching a smoker's clothing, a child may suffer extremely dangerous nervous system injury, then clearly we don't have any credibility. So then, what is the chance that the public will believe us when we actually tell the truth? It's like the Boy Who Cried Wolf. Once we lose public trust, we will lose credibility even when we are making statements that are well-supported by scientific evidence.
Tuesday, October 12, 2010
Chair of NIH Smoking Cessation Panel May Have Made Incomplete Conflict of Interest Disclosures
According to his own sworn testimony, the chair of the expert panel which in 2008 released national recommendations for the use of smoking cessation medications by physicians received (at the time) up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.
In addition, according to his own 2008 JAMA article: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."
The Rest of the Story
Despite this huge financial conflict of interest with Big Pharma, the panel chair - Dr. Michael Fiore - failed to recuse himself from the panel and the panel organizers failed to remove him from the panel.
But perhaps even worse, Dr. Fiore apparently failed to disclose all of his financial conflicts of interest in his initial financial disclosure required for his participation on the panel. The disclosure form asks for "complete" disclosure of all conflicts over the past 5 years. On the form, Dr. Fiore denied any current honoraria or consulting arrangements with pharmaceutical companies, but apparently failed to disclose the fact (based on his own testimony) that: "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."
The financial disclosure form asked for disclosure of all conflicts of interest in the past five years. The financial disclosure form for the Clinical Practice Guideline was signed in 2006, meaning that Dr. Fiore should have disclosed any and all consulting work with pharmaceutical companies dating back to 2001. Dr. Fiore's testimony in the DOJ lawsuit was in 2005, meaning that he admitted doing pharmaceutical consulting work during the period 2001-2005 ranging between $10,000 and $40,000 per year. I do not find this consulting work disclosed on the primary financial disclosure form signed by Dr. Fiore on September 5, 2006.
Although the form does note that Dr. Fiore was named to an endowed Chair position made possible by an unrestricted gift from GlaxoWellcome, the disclosure fails to mention that receives up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.
According to his testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."
A Wall Street Journal article of February 8, 2007 reports that: "Between 1999 and 2004, Dr. Fiore personally pocketed $10,000 to $40,000 a year from the quitting-aid industry for honorariums and consulting work. He says he stopped such work in 2005." This article corroborates the information from other sources that Dr. Fiore had pharmaceutical-related consultancy income for the years 2002-2004 that should have been reported on the Clinical Practice Guideline initial disclosure form.
Thus, in the five-year period asked about in the primary disclosure form for the panel, it appears that Dr. Fiore should, at very least, have reported his lectures and consultation for Pfizer. In addition, it appears that he also should have reported his serving as an investigator on research grants funded by four pharmaceutical companies.
I do not understand why it appears that Dr. Fiore failed to disclose his consultant work for pharmaceutical companies on the primary disclosure form. In his testimony, he acknowledges receiving between $10,000 and $40,000 annually from pharmaceutical companies for consulting work during the period 2001-2005. However, I would interpret his primary financial disclosure form to indicate that he has not done any consultant work for the pharmaceutical companies for the past 5 years (that is, from 2002-2006). This appears to be inconsistent with the testimony, and therefore it appears to be inaccurate.
The disclosure form states: "In keeping with recent JAMA recommendations, Dr. Fiore does not accept honorarium nor do consulting work for the pharmaceutical industry."
Since the form requires disclosure of all financial interests during the past 5 years, the interpretation of this disclosure statement is that Dr. Fiore does not currently do consulting work for the pharmaceutical industry, and has not done such consulting work for the past 5 years.
Based on Dr. Fiore's testimony, this appears not to be true. Thus, this appears to be a dishonest, or at very least, a severely flawed and incomplete disclosure.
The fact that Dr. Fiore later disclosed 2005 consultant payments from one pharmaceutical company does not compensate for the failure to disclose similar conflicts during the years 2002-2006, which were specifically asked about in the primary disclosure form.
A second apparent failed disclosure of Dr. Fiore's financial conflicts of interest is an article in a 2008 issue of the American Journal of Public Health. Dr. Fiore and co-authors examine the effect of smoking cessation media campaigns among socioeconomically advantaged and disadvantaged populations (see: Niederdeppe J., Fiore MC, Baker TB, Smith SS. Smoking-cessation media campaigns and their effectiveness among socioeconomically advantaged and disadvantaged populations. Am J Public Health 2008; 98:916-924).
In the paper, the authors make a push for increased access to pharmaceutical treatment for smoking cessation. They point out that access to these pharmaceuticals is a major barrier for less-educated populations: "Less-educated populations face more barriers in turning a quit attempt into smoking abstinence, including fewer smoking restrictions at work, greater nicotine dependence, and less access to evidence-based treatments. Future campaigns should keep these barriers in mind when developing campaigns to promote quitting among lower-SES populations."
The paper's push for greater access to pharmaceuticals does not come from authors who are objective. In fact, Dr. Fiore has a history of very close financial connections to a number of pharmaceutical companies which manufacture smoking cessation products and thus stand to gain financially if his advice is heeded. However, these financial relationships are not disclosed anywhere in the paper.
The paper does acknowledge financial support from the Robert Wood Johnson Foundation and from the National Institutes of Health. However, it does not disclose the financial conflicts of interest of Dr. Fiore. It appears that there is really no way for article readers to know that Dr. Fiore has had severe conflicts of interest which could lead them to question his objectivity in making a recommendation for the greater use of pharmaceuticals. I find this to be quite unfortunate.
Whether Dr. Fiore has important conflicts of interest that ought to be disclosed does not seem to be at issue here. Because in an article published on almost the exact same day as the AJPH article, Dr. Fiore discloses in a 2008 JAMA article that he does indeed have important conflicts of interest. That article states: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis. In 1998, the UW appointed him to a named chair, made possible by an unrestricted gift to the UW from GlaxoWellcome."
Does it not seem important for readers of his AJPH article to also know that Dr. Fiore has lectured and consulted for companies which manufacture smoking cessation products and that his chair position was endowed by one such pharmaceutical company?
In my opinion, this is unfortunate. I believe it represents a failed disclosure of an important conflict of interest. I suppose it is possible that Dr. Fiore did disclose the conflict but AJPH chose not to publish it. However, it seems to me that an author can insist that the journal include such a disclosure statement in the Acknowledgments section of the article.
To be clear, I am not suggesting that there was anything more than a mistake - a failed disclosure - made in these two situations. I'm not arguing that there was wrongdoing or violation of any policy or rule. However, the fact that the readers of the AJPH article are not immediately aware of the conflict of interest is problematic. As is the fact that the initial disclosure for the expert panel appears to be incomplete.
While I do not necessarily think there is anything wrong with accepting money from pharmaceutical companies to examine the use and effectiveness of their products, I do think it is wrong when such conflicts of interest are not disclosed to the public. And I think these conflicts need to be disclosed in all relevant publications, not just some of them.
Because of the importance of this issue, I would certainly hope that Dr. Fiore would correct these two failed or incomplete conflict of interest disclosures. Everyone makes mistakes (I have made my share) and mistakes may be particularly common with conflict of interest disclosures. However, the most important thing is that once a mistake is identified, the individual promptly corrects that mistake. I do not hold these apparent mistakes against Dr. Fiore. I do, however, think that they must be corrected. And I think that such complete transparency and honesty is necessary not because of any individual wrongdoing, but because the integrity of our national policy regarding smoking cessation depends on it.
In addition, according to his own 2008 JAMA article: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."
The Rest of the Story
Despite this huge financial conflict of interest with Big Pharma, the panel chair - Dr. Michael Fiore - failed to recuse himself from the panel and the panel organizers failed to remove him from the panel.
But perhaps even worse, Dr. Fiore apparently failed to disclose all of his financial conflicts of interest in his initial financial disclosure required for his participation on the panel. The disclosure form asks for "complete" disclosure of all conflicts over the past 5 years. On the form, Dr. Fiore denied any current honoraria or consulting arrangements with pharmaceutical companies, but apparently failed to disclose the fact (based on his own testimony) that: "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."
The financial disclosure form asked for disclosure of all conflicts of interest in the past five years. The financial disclosure form for the Clinical Practice Guideline was signed in 2006, meaning that Dr. Fiore should have disclosed any and all consulting work with pharmaceutical companies dating back to 2001. Dr. Fiore's testimony in the DOJ lawsuit was in 2005, meaning that he admitted doing pharmaceutical consulting work during the period 2001-2005 ranging between $10,000 and $40,000 per year. I do not find this consulting work disclosed on the primary financial disclosure form signed by Dr. Fiore on September 5, 2006.
Although the form does note that Dr. Fiore was named to an endowed Chair position made possible by an unrestricted gift from GlaxoWellcome, the disclosure fails to mention that receives up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.
According to his testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."
A Wall Street Journal article of February 8, 2007 reports that: "Between 1999 and 2004, Dr. Fiore personally pocketed $10,000 to $40,000 a year from the quitting-aid industry for honorariums and consulting work. He says he stopped such work in 2005." This article corroborates the information from other sources that Dr. Fiore had pharmaceutical-related consultancy income for the years 2002-2004 that should have been reported on the Clinical Practice Guideline initial disclosure form.
Thus, in the five-year period asked about in the primary disclosure form for the panel, it appears that Dr. Fiore should, at very least, have reported his lectures and consultation for Pfizer. In addition, it appears that he also should have reported his serving as an investigator on research grants funded by four pharmaceutical companies.
I do not understand why it appears that Dr. Fiore failed to disclose his consultant work for pharmaceutical companies on the primary disclosure form. In his testimony, he acknowledges receiving between $10,000 and $40,000 annually from pharmaceutical companies for consulting work during the period 2001-2005. However, I would interpret his primary financial disclosure form to indicate that he has not done any consultant work for the pharmaceutical companies for the past 5 years (that is, from 2002-2006). This appears to be inconsistent with the testimony, and therefore it appears to be inaccurate.
The disclosure form states: "In keeping with recent JAMA recommendations, Dr. Fiore does not accept honorarium nor do consulting work for the pharmaceutical industry."
Since the form requires disclosure of all financial interests during the past 5 years, the interpretation of this disclosure statement is that Dr. Fiore does not currently do consulting work for the pharmaceutical industry, and has not done such consulting work for the past 5 years.
Based on Dr. Fiore's testimony, this appears not to be true. Thus, this appears to be a dishonest, or at very least, a severely flawed and incomplete disclosure.
The fact that Dr. Fiore later disclosed 2005 consultant payments from one pharmaceutical company does not compensate for the failure to disclose similar conflicts during the years 2002-2006, which were specifically asked about in the primary disclosure form.
A second apparent failed disclosure of Dr. Fiore's financial conflicts of interest is an article in a 2008 issue of the American Journal of Public Health. Dr. Fiore and co-authors examine the effect of smoking cessation media campaigns among socioeconomically advantaged and disadvantaged populations (see: Niederdeppe J., Fiore MC, Baker TB, Smith SS. Smoking-cessation media campaigns and their effectiveness among socioeconomically advantaged and disadvantaged populations. Am J Public Health 2008; 98:916-924).
In the paper, the authors make a push for increased access to pharmaceutical treatment for smoking cessation. They point out that access to these pharmaceuticals is a major barrier for less-educated populations: "Less-educated populations face more barriers in turning a quit attempt into smoking abstinence, including fewer smoking restrictions at work, greater nicotine dependence, and less access to evidence-based treatments. Future campaigns should keep these barriers in mind when developing campaigns to promote quitting among lower-SES populations."
The paper's push for greater access to pharmaceuticals does not come from authors who are objective. In fact, Dr. Fiore has a history of very close financial connections to a number of pharmaceutical companies which manufacture smoking cessation products and thus stand to gain financially if his advice is heeded. However, these financial relationships are not disclosed anywhere in the paper.
The paper does acknowledge financial support from the Robert Wood Johnson Foundation and from the National Institutes of Health. However, it does not disclose the financial conflicts of interest of Dr. Fiore. It appears that there is really no way for article readers to know that Dr. Fiore has had severe conflicts of interest which could lead them to question his objectivity in making a recommendation for the greater use of pharmaceuticals. I find this to be quite unfortunate.
Whether Dr. Fiore has important conflicts of interest that ought to be disclosed does not seem to be at issue here. Because in an article published on almost the exact same day as the AJPH article, Dr. Fiore discloses in a 2008 JAMA article that he does indeed have important conflicts of interest. That article states: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis. In 1998, the UW appointed him to a named chair, made possible by an unrestricted gift to the UW from GlaxoWellcome."
Does it not seem important for readers of his AJPH article to also know that Dr. Fiore has lectured and consulted for companies which manufacture smoking cessation products and that his chair position was endowed by one such pharmaceutical company?
In my opinion, this is unfortunate. I believe it represents a failed disclosure of an important conflict of interest. I suppose it is possible that Dr. Fiore did disclose the conflict but AJPH chose not to publish it. However, it seems to me that an author can insist that the journal include such a disclosure statement in the Acknowledgments section of the article.
To be clear, I am not suggesting that there was anything more than a mistake - a failed disclosure - made in these two situations. I'm not arguing that there was wrongdoing or violation of any policy or rule. However, the fact that the readers of the AJPH article are not immediately aware of the conflict of interest is problematic. As is the fact that the initial disclosure for the expert panel appears to be incomplete.
While I do not necessarily think there is anything wrong with accepting money from pharmaceutical companies to examine the use and effectiveness of their products, I do think it is wrong when such conflicts of interest are not disclosed to the public. And I think these conflicts need to be disclosed in all relevant publications, not just some of them.
Because of the importance of this issue, I would certainly hope that Dr. Fiore would correct these two failed or incomplete conflict of interest disclosures. Everyone makes mistakes (I have made my share) and mistakes may be particularly common with conflict of interest disclosures. However, the most important thing is that once a mistake is identified, the individual promptly corrects that mistake. I do not hold these apparent mistakes against Dr. Fiore. I do, however, think that they must be corrected. And I think that such complete transparency and honesty is necessary not because of any individual wrongdoing, but because the integrity of our national policy regarding smoking cessation depends on it.
Friday, October 08, 2010
Not Making Sense: Health Professionals Giving Misleading Advice About Electronic Cigarettes
It's one thing to give out misleading or misguided advice. It's another thing to do so when you really don't know what you're talking about.
Yet this is exactly what is happening, it appears, with advice from a number of health professionals on the use of electronic cigarettes.
In an article in the New York Daily News (which was prompted by Katherine Heigl's vaping demonstration on the David Letterman show), the medical director of the Cardiac and Pulmonary Wellness and Rehabilitation Program at NYU Langone Medical Center was quoted as urging people not to use electronic cigarettes because: "It’s nicotine, it’s a drug, it’s addictive and it has health consequences." Instead, the physician recommends that people use nicotine replacement products.
Moreover, the physician apparently told the newspaper that: "some of the chemicals in the propellant that helps to vaporize the nicotine are dangerous."
In addition, he apparently stated that electronic cigarettes "are not a good way or an approved way to quit smoking."
Another physician, who is an internist and pulmonary specialist at Lenox Hill Hospital, was quoted as telling the public: "inhaling fumes from the plastic tubes can be carcinogenic."
Also in the article, a respiratory therapist was quoted as stating: "At this point, they are a drug delivery service. It’s a little cigarette that lets you inhale nicotine. And inhalation is the fastest route of drug delivery. I do not recommend them."
The Rest of the Story
Let's take each of these public statements, one at a time:
1. "It’s nicotine, it’s a drug, it’s addictive and it has health consequences."
The very same can be said of each of the following products: nicotine patches, nicotine gum, and nicotine inhalers.
Does that mean that nicotine replacement therapy should not be recommended by physicians? Obviously not. In fact, the same physician who argued against the use of electronic cigarettes because they deliver nicotine recommended the use of nicotine replacement products. Does he not understand that what makes a smoking cessation product effective is that it delivers nicotine? If the product did not deliver nicotine or somehow affect nicotine receptors or the ensuing chemical effects, it would not be effective for smoking cessation.
In other words, the statement is nonsensical.
Nevertheless, it was offered as national advice to a national audience of readers.
2. "Some of the chemicals in the propellant that helps to vaporize the nicotine are dangerous."
Name one.
Other than diethylene glycol, which has been found in only one brand of electronic cigarettes (and which has been confirmed not to be present in all other brands that have been tested in studies available online), I challenge the physician or anyone else making such a statement to name one chemical in the propellant which has been demonstrated to be dangerous to humans at the level at which it is inhaled in electronic cigarette vapor.
There simply is no evidence to support this statement. One could state that the risks are unknown and that a chemical in the propellant might be dangerous, but to state that some of the chemicals are dangerous is unsupported by any scientific evidence, and therefore, irresponsible.
3. Electronic cigarettes "are not a good way ... to quit smoking."
Where is the evidence to support such a statement? I could certainly understand a statement that we don't know whether electronic cigarettes are a good way to quit smoking because there are not scientific studies which have examined the issues. But in the absence of such studies, how can one claim that they are not a good way to quit? How can you know the answer to the question before you have tried to answer it?
There is tremendous anecdotal evidence, from the experience of vapers, that electronic cigarettes are indeed a very effective way of quitting smoking. While it is understandable that one might require more systematic evidence before proclaiming that they are a good way to quit smoking, there is absolutely no evidence that they are a bad way to quit smoking. The statement is unfounded.
4. "Inhaling fumes from the plastic tubes can be carcinogenic."
Where is the evidence that vapers are being exposed to carcinogens from the plastic tubing of electronic cigarettes.
I defy anyone making such a claim to show me the scientific study in which it was shown that vapers are exposed to carcinogens from the plastic tubing.
Until such a study is conducted, the statement is unsupported and irresponsible.
5. "At this point, they are a drug delivery service. It ... lets you inhale nicotine. And inhalation is the fastest route of drug delivery. I do not recommend them."
The very same is true of nicotine inhalers. Does the respiratory therapist also advise people not to use nicotine inhalers?
The rest of the story is that some health professionals are apparently providing uninformed, misinformed, misguided, and/or nonsensical advice to the public regarding electronic cigarettes.
Why is there such a disconnect between actual scientific evidence and advice about electronic cigarettes? I have two hypotheses:
First, I think that many health practitioners have an ideological barrier in place. They simply cannot accept that a behavior that looks like smoking could possibly be recommended, even if it greatly improves people's health.
Second, I think that many health practitioners are influenced, directly or indirectly, by marketing or funding by pharmaceutical companies, and thus they have a bias toward protecting the profits of nicotine replacement products. I have no idea if this is the case with the above example, but it is certainly true of the anti-smoking groups which have called for the removal of electronic cigarettes from the market.
Some combination of these two factors is precluding many health practitioners and anti-smoking groups from giving reasonable, science-based and science-guided advice to the public on the issue of electronic cigarette use.
Yet this is exactly what is happening, it appears, with advice from a number of health professionals on the use of electronic cigarettes.
In an article in the New York Daily News (which was prompted by Katherine Heigl's vaping demonstration on the David Letterman show), the medical director of the Cardiac and Pulmonary Wellness and Rehabilitation Program at NYU Langone Medical Center was quoted as urging people not to use electronic cigarettes because: "It’s nicotine, it’s a drug, it’s addictive and it has health consequences." Instead, the physician recommends that people use nicotine replacement products.
Moreover, the physician apparently told the newspaper that: "some of the chemicals in the propellant that helps to vaporize the nicotine are dangerous."
In addition, he apparently stated that electronic cigarettes "are not a good way or an approved way to quit smoking."
Another physician, who is an internist and pulmonary specialist at Lenox Hill Hospital, was quoted as telling the public: "inhaling fumes from the plastic tubes can be carcinogenic."
Also in the article, a respiratory therapist was quoted as stating: "At this point, they are a drug delivery service. It’s a little cigarette that lets you inhale nicotine. And inhalation is the fastest route of drug delivery. I do not recommend them."
The Rest of the Story
Let's take each of these public statements, one at a time:
1. "It’s nicotine, it’s a drug, it’s addictive and it has health consequences."
The very same can be said of each of the following products: nicotine patches, nicotine gum, and nicotine inhalers.
Does that mean that nicotine replacement therapy should not be recommended by physicians? Obviously not. In fact, the same physician who argued against the use of electronic cigarettes because they deliver nicotine recommended the use of nicotine replacement products. Does he not understand that what makes a smoking cessation product effective is that it delivers nicotine? If the product did not deliver nicotine or somehow affect nicotine receptors or the ensuing chemical effects, it would not be effective for smoking cessation.
In other words, the statement is nonsensical.
Nevertheless, it was offered as national advice to a national audience of readers.
2. "Some of the chemicals in the propellant that helps to vaporize the nicotine are dangerous."
Name one.
Other than diethylene glycol, which has been found in only one brand of electronic cigarettes (and which has been confirmed not to be present in all other brands that have been tested in studies available online), I challenge the physician or anyone else making such a statement to name one chemical in the propellant which has been demonstrated to be dangerous to humans at the level at which it is inhaled in electronic cigarette vapor.
There simply is no evidence to support this statement. One could state that the risks are unknown and that a chemical in the propellant might be dangerous, but to state that some of the chemicals are dangerous is unsupported by any scientific evidence, and therefore, irresponsible.
3. Electronic cigarettes "are not a good way ... to quit smoking."
Where is the evidence to support such a statement? I could certainly understand a statement that we don't know whether electronic cigarettes are a good way to quit smoking because there are not scientific studies which have examined the issues. But in the absence of such studies, how can one claim that they are not a good way to quit? How can you know the answer to the question before you have tried to answer it?
There is tremendous anecdotal evidence, from the experience of vapers, that electronic cigarettes are indeed a very effective way of quitting smoking. While it is understandable that one might require more systematic evidence before proclaiming that they are a good way to quit smoking, there is absolutely no evidence that they are a bad way to quit smoking. The statement is unfounded.
4. "Inhaling fumes from the plastic tubes can be carcinogenic."
Where is the evidence that vapers are being exposed to carcinogens from the plastic tubing of electronic cigarettes.
I defy anyone making such a claim to show me the scientific study in which it was shown that vapers are exposed to carcinogens from the plastic tubing.
Until such a study is conducted, the statement is unsupported and irresponsible.
5. "At this point, they are a drug delivery service. It ... lets you inhale nicotine. And inhalation is the fastest route of drug delivery. I do not recommend them."
The very same is true of nicotine inhalers. Does the respiratory therapist also advise people not to use nicotine inhalers?
The rest of the story is that some health professionals are apparently providing uninformed, misinformed, misguided, and/or nonsensical advice to the public regarding electronic cigarettes.
Why is there such a disconnect between actual scientific evidence and advice about electronic cigarettes? I have two hypotheses:
First, I think that many health practitioners have an ideological barrier in place. They simply cannot accept that a behavior that looks like smoking could possibly be recommended, even if it greatly improves people's health.
Second, I think that many health practitioners are influenced, directly or indirectly, by marketing or funding by pharmaceutical companies, and thus they have a bias toward protecting the profits of nicotine replacement products. I have no idea if this is the case with the above example, but it is certainly true of the anti-smoking groups which have called for the removal of electronic cigarettes from the market.
Some combination of these two factors is precluding many health practitioners and anti-smoking groups from giving reasonable, science-based and science-guided advice to the public on the issue of electronic cigarette use.
Thursday, October 07, 2010
More Science by Press Release: This Time, It's Thirdhand Smoke Dangers
In the latest example of what I call "science by press release," researchers at the Hohenstein Institute in Germany have issued a press release to publicize the findings of new research which they claim shows that thirdhand smoke carried on the clothing of smokers is hazardous to young children.
The problem?
There is no published study, no online study, no study of any kind being made available and the researchers have declined to share their study with anyone until it is reviewed by a journal and published. Thus, there is no basis for anyone to evaluate the validity of the reported findings. Meanwhile, however, word of the terrible hazards to babies posed by clothing of smokers is spreading worldwide through the media (for example, this article warns that "toxic substances on clothing could damage health of infants").
To make matters worse still, Action on Smoking and Health has issued its own press release, headlined "Tobacco Smoke Residue Causes Massive Damage in Babies' Skin," which warns that: "Parents who do not smoke in the presence of their children, including even those who smoke only outdoors, nevertheless put their children at serious risk of "massive damage" to both skin and nerve cells, since a neurotoxin in thirdhand tobacco smoke penetrates the child's skin, according to recent research in Germany."
ASH is using the new "study" findings to argue that: "court orders aimed at protecting children from parental smoking may have to be expanded to protect them from the toxic chemicals in tobacco smoke residues which are far higher than in smokey air."
The Hohenstein Institute press release states: "the scientists at the IHB used a specially developed cell culture model of baby skin - a 3D skin model, the cell composition, structure and properties of which imitate the skin of babies and toddlers. To simulate the effects of thirdhand smoke, a T-shirt was deliberately impregnated with nicotine, the main toxic ingredient of cigarettes, just like during a smoker's break on the balcony. So that the quantity of the toxin could be verified afterwards, radioactively marked nicotine was used. Then the smoke-impregnated textiles were placed on the baby skin and the penetration of the nicotine into the skin was tracked in tracer studies. The results produced by the Hohenstein scientists showed for the first time that the neurotoxin nicotine is not only released from clothing by perspiration so that it can be detected in all the layers of baby skin, but it is also transported through the skin into deeper tissue layers." ...
"in the laboratory experiment, the toxins from the cigarette smoke that were dissolved in the perspiration caused massive damage to the skin cells; for example, they changed their shape and even, where the concentration was high, died off. Similarly, nerve cells, which are particularly active during the early stages of development, showed clear changes and were no longer able to connect properly with one another."
The Rest of the Story
Science by press release is inappropriate because the findings are disseminated widely by the media without any opportunity for others to scrutinize the work. The findings must be accepted on faith. Therefore, it is impossible to judge whether the conclusions of the study are valid or not. And if the conclusions turn out to be unwarranted, then it will be too late to reverse them. The media have already disseminated the conclusion widely. Any correction given down the road would have little effect.
In most cases, I believe the results of a scientific study should not be released to the media prior to publication. However, if the results of a study are going to be released to the media, then I believe it is imperative that the study itself be made available for public scrutiny. You can't just release the conclusions, but not the study itself.
Moreover, if the manuscript is going to be submitted for publication, then it may be inappropriate to release the findings to the media prior to publication. Many journals have explicit policies that preclude the authors of submitted manuscripts from releasing the results to the media until publication.
It is problematic that the study authors have apparently released their results and conclusions to the media but that they have not released the full results and methods of the study because without the full methods and results, it is not possible for others in the field to adequately review the work and assess its validity. I personally feel that researchers should not publicize study findings through the media prior to publication unless they are willing to make the full findings and methods available. Releasing results via press release to the media should not be done until publication, or if it needs to be done before publication, then it should only be done with concomitant release of the entire study.
In this case, the science by press release approach does damage. The research itself does not demonstrate that there is any clinically significant effect of a young child being exposed to the clothing of a smoker. While the study examines the effect of residues in a skin cell culture model, it does not demonstrate actual skin damage "in real life." Moreover, the neurotoxicity is only a theoretical concern: the study provides no evidence that actual neurological damage occurs as a result of having contact with the clothes of a smoker.
Of course, this didn't stop ASH from spreading unsupported conclusions widely through the media. ASH proclaims that exposure to the clothing of smokers causes "massive damage" to babies' skin and to their nerve cells as well. This claim is completely unsupported, even by the research cited, because there is no evidence of any clinically significant effect of exposure to smokers' clothing.
Frankly, I'm not even aware of any reports of skin damage to babies caused by direct contact with smoke residues in the presence of active smoking in the home. So the claim that contact with a smoker's clothing is going to cause "massive damage" to the skin is far-fetched and unsupported scientifically.
Sadly, ASH is using this new "study" to urge courts to take draconian measures that are not supported by scientific evidence.
What is clear is that ASH has no interest in actual scientific accuracy or scientific rigor. It is merely interested in disseminating tabloid news that will support its pre-ordained policy agenda.
(Thanks to Michael McFadden for the tip.)
The problem?
There is no published study, no online study, no study of any kind being made available and the researchers have declined to share their study with anyone until it is reviewed by a journal and published. Thus, there is no basis for anyone to evaluate the validity of the reported findings. Meanwhile, however, word of the terrible hazards to babies posed by clothing of smokers is spreading worldwide through the media (for example, this article warns that "toxic substances on clothing could damage health of infants").
To make matters worse still, Action on Smoking and Health has issued its own press release, headlined "Tobacco Smoke Residue Causes Massive Damage in Babies' Skin," which warns that: "Parents who do not smoke in the presence of their children, including even those who smoke only outdoors, nevertheless put their children at serious risk of "massive damage" to both skin and nerve cells, since a neurotoxin in thirdhand tobacco smoke penetrates the child's skin, according to recent research in Germany."
ASH is using the new "study" findings to argue that: "court orders aimed at protecting children from parental smoking may have to be expanded to protect them from the toxic chemicals in tobacco smoke residues which are far higher than in smokey air."
The Hohenstein Institute press release states: "the scientists at the IHB used a specially developed cell culture model of baby skin - a 3D skin model, the cell composition, structure and properties of which imitate the skin of babies and toddlers. To simulate the effects of thirdhand smoke, a T-shirt was deliberately impregnated with nicotine, the main toxic ingredient of cigarettes, just like during a smoker's break on the balcony. So that the quantity of the toxin could be verified afterwards, radioactively marked nicotine was used. Then the smoke-impregnated textiles were placed on the baby skin and the penetration of the nicotine into the skin was tracked in tracer studies. The results produced by the Hohenstein scientists showed for the first time that the neurotoxin nicotine is not only released from clothing by perspiration so that it can be detected in all the layers of baby skin, but it is also transported through the skin into deeper tissue layers." ...
"in the laboratory experiment, the toxins from the cigarette smoke that were dissolved in the perspiration caused massive damage to the skin cells; for example, they changed their shape and even, where the concentration was high, died off. Similarly, nerve cells, which are particularly active during the early stages of development, showed clear changes and were no longer able to connect properly with one another."
The Rest of the Story
Science by press release is inappropriate because the findings are disseminated widely by the media without any opportunity for others to scrutinize the work. The findings must be accepted on faith. Therefore, it is impossible to judge whether the conclusions of the study are valid or not. And if the conclusions turn out to be unwarranted, then it will be too late to reverse them. The media have already disseminated the conclusion widely. Any correction given down the road would have little effect.
In most cases, I believe the results of a scientific study should not be released to the media prior to publication. However, if the results of a study are going to be released to the media, then I believe it is imperative that the study itself be made available for public scrutiny. You can't just release the conclusions, but not the study itself.
Moreover, if the manuscript is going to be submitted for publication, then it may be inappropriate to release the findings to the media prior to publication. Many journals have explicit policies that preclude the authors of submitted manuscripts from releasing the results to the media until publication.
It is problematic that the study authors have apparently released their results and conclusions to the media but that they have not released the full results and methods of the study because without the full methods and results, it is not possible for others in the field to adequately review the work and assess its validity. I personally feel that researchers should not publicize study findings through the media prior to publication unless they are willing to make the full findings and methods available. Releasing results via press release to the media should not be done until publication, or if it needs to be done before publication, then it should only be done with concomitant release of the entire study.
In this case, the science by press release approach does damage. The research itself does not demonstrate that there is any clinically significant effect of a young child being exposed to the clothing of a smoker. While the study examines the effect of residues in a skin cell culture model, it does not demonstrate actual skin damage "in real life." Moreover, the neurotoxicity is only a theoretical concern: the study provides no evidence that actual neurological damage occurs as a result of having contact with the clothes of a smoker.
Of course, this didn't stop ASH from spreading unsupported conclusions widely through the media. ASH proclaims that exposure to the clothing of smokers causes "massive damage" to babies' skin and to their nerve cells as well. This claim is completely unsupported, even by the research cited, because there is no evidence of any clinically significant effect of exposure to smokers' clothing.
Frankly, I'm not even aware of any reports of skin damage to babies caused by direct contact with smoke residues in the presence of active smoking in the home. So the claim that contact with a smoker's clothing is going to cause "massive damage" to the skin is far-fetched and unsupported scientifically.
Sadly, ASH is using this new "study" to urge courts to take draconian measures that are not supported by scientific evidence.
What is clear is that ASH has no interest in actual scientific accuracy or scientific rigor. It is merely interested in disseminating tabloid news that will support its pre-ordained policy agenda.
(Thanks to Michael McFadden for the tip.)
Tuesday, October 05, 2010
Canadian Anti-Smoking Group Attacking Casa Cubana for Flouting Flavored Tobacco Ban
According to a CTV article, the Canadian Cancer Society is attacking the tobacco industry - Casa Cubana in particular - for flouting a new tobacco law that bans flavored cigarettes and small cigars.
The ban on flavored cigarettes and small cigars did not extend to larger cigars (more than 1.4 grams in weight). In addition, the ban only includes fruit flavorings, not menthol.
In response to the ban, Casa Cubana made some of its cigars larger so that they exceed the 1.4 grams weight limit and are therefore not subject to the flavoring ban. The Canadian Cancer Society has attacked Casa Cubana, arguing that the company is flouting the law.
According to the article: "Tobacco companies are being accused of skirting highly publicized federal legislation -- announced by Prime Minister Stephen Harper -- designed to keep kids from getting hooked on flavoured cigarettes. Importers of those little cigarillos that come in flavours like vanilla, strawberry and peach have changed the size and characteristics on their product in order to get them in the country. One anti-smoking advocate describes it as a direct reaction to the law and an attempt to circumvent it. "It's a game of cat and mouse," according to Rob Cunningham of the Canadian Cancer Society" ...
The ban on flavored cigarettes and small cigars did not extend to larger cigars (more than 1.4 grams in weight). In addition, the ban only includes fruit flavorings, not menthol.
In response to the ban, Casa Cubana made some of its cigars larger so that they exceed the 1.4 grams weight limit and are therefore not subject to the flavoring ban. The Canadian Cancer Society has attacked Casa Cubana, arguing that the company is flouting the law.
According to the article: "Tobacco companies are being accused of skirting highly publicized federal legislation -- announced by Prime Minister Stephen Harper -- designed to keep kids from getting hooked on flavoured cigarettes. Importers of those little cigarillos that come in flavours like vanilla, strawberry and peach have changed the size and characteristics on their product in order to get them in the country. One anti-smoking advocate describes it as a direct reaction to the law and an attempt to circumvent it. "It's a game of cat and mouse," according to Rob Cunningham of the Canadian Cancer Society" ...
"The law defines little cigars as any product that weighs 1.4 grams or less and uses a cigarette filter. So the cigars are now slightly heavier and the filters are gone. Extra tobacco now fills in the spot where the filters used to be. Casa Cubana, a Montreal-based company that imports various brands, maintains its products remain legal because they do not qualify as "little cigars" under the new federal definition." ...
"Cunningham, the senior policy analyst at the Canadian Cancer Society, says flavoured cigarillos didn't exist as a product in Canada 10 years ago, but that sales have skyrocketed.'For us it's absolutely unacceptable that you can flavour a tobacco product with fruit, ice cream and candy flavours to make it taste better and easier to smoke,' he said. Cunningham also complains that unlike cigarette packs that carry health warnings on both sides, the little cigar packages have warnings only on the back."
"But Luc Martial, who handles government affairs for Casa Cubana, says there's no research that proves flavoured cigars attract kids to smoking. If that were true, he says, the federal government could have simply banned flavoured tobacco. 'There is absolutely no proof -- in government or out -- that suggests kids start or continue smoking because of flavours," Martial said. ... He says statistics reveal that at its peak in 2009, the flavoured tobacco market in Canada represented less than half of one per cent of tobacco consumed in the country."
The Rest of the Story
It makes absolutely no sense for the Canadian Cancer Society to be complaining about the possibility that a few youths might be attracted to try flavored cigars when the Society supported legislation which exempted menthol cigarettes, which are being smoked by a huge proportion of Canadian youth, yet the Society does not suggest that these menthol cigarettes represent a problem.
How is it that Casa Cubana is flouting the law because it sells flavored cigars - which are exempt under the law - but Imperial Tobacco is not flouting the law because it sells flavored cigarettes (Peter Jackson Menthols) which are exempt under the law?
The truth is that Casa Cubana is not flouting the law, they are complying with it. And the only one who the Canadian Cancer Society has to blame for this is itself and the policy makers who enacted the law. If the intent was to prohibit the sale of flavored tobacco products, then they should have prohibited the sale of flavored tobacco products. They should have included all tobacco products, rather than exempted cigars. And they should have included menthol in the ban, since those are by far the most popular type of flavored cigarette used by youths and adults alike in Canada. In fact, they are the only type of flavored cigarette with any substantial market share.
I don't understand why anti-smoking organizations continue to complain when tobacco companies take actions that are in compliance with the law. The same thing occurred here in the United States when cigarette companies removed "light" brands from the market. They needed to identify these brands in some way so they used different colors. Anti-smoking groups promptly attacked them for flouting the law. But the truth is that they were complying with the law, and if it had been the intention of anti-smoking groups to get rid of "light" brands, then they should have done so.
You can't pass a law with truck-size loopholes and exemptions and then come back and attack the cigarette companies for complying with those exemptions. Why not actually show some courage and take the actions which will actually make a difference in the first place.
Clearly, what is going on in Canada is the same as in the States: anti-smoking groups and politicians are trying to make it look like they are doing something to reduce tobacco use, but they are actually working around the margins and taking politically easy actions which do nothing to substantially affect the cigarette market.
They are clearly interested in political victories, not making a major dent in youth smoking rates.
Monday, October 04, 2010
San Francisco Board of Supervisors Considering a Bill to Ban Toys in McDonald's Happy Meals
I'm not joking.
The San Francisco Board of Supervisors - which last month voted to ban tobacco sales in all pharmacies -- is, indeed, considering an ordinance which would ban the inclusion of toys in McDonald's Happy Meals, unless the meals include fruits or vegetables and limit the total calories to a specified value.
San Francisco would not be the first local government to take such an action. Last summer, Santa Clara County implemented an ordinance which bans toys from food promotions aimed at children (it only covers unincorporated areas of the county).
In addition, the Center for Science in the Public Interest (CSPI) has threatened to sue McDonald's over its inclusion of toys in Happy Meals.
The San Francisco ordinance would affect not only McDonald's Happy Meals, but any fast food toy giveaways, including Burger King's Kids Meals, which include a toy.
The Rest of the Story
It may come as a surprise to the San Francisco Board of Supervisors, but it is not the toys which are causing childhood obesity, it is the food. If this degree of intrusion into the marketing of legal products is justified, then so is a more direct approach of simply regulating the food that can or cannot be sold to children. Obviously, such an approach is beyond the appropriate role of government.
Moreover, this issue is not as simple as it might appear.
A typical Burger King Kids Meal includes a hamburger, fat free milk, and apple slices, and supplies 430 calories and 10.5 grams of fat.
If instead of a Kids Meal, a parent insisted on his kid having a Garden Salad and fat free milk only, the meal would supply 430 calories and 26 grams of fat.
So the garden salad and fat free milk option provides the exact same number of calories as the Kids Meal. However, the Kids Meal is far healthier, because it supplies only 10.5 grams of fat compared to 26 grams of fat in the garden salad "healthy" meal.
Is the San Francisco Board of Supervisors also going to ban the provision of toys in garden salads sold to children? Why not just ban the sale of garden salads to children, since at Burger King, these salads contain a "whopping" 26 grams of fat.
In fact, a regular hamburger at Burger King is "healthier" than a garden salad. The hamburger has 260 calories and 10 grams of fat, while the garden salad has 330 calories and 26 grams of fat.
At McDonalds, ordering a hamburger provides less fat than ordering a salad with regular dressing (9 grams of fat compared to 15 grams).
If you're worried about sodium intake, a hamburger and a child's Coke at McDonalds provide less sodium than a garden salad and an apple juice box, while providing 50 fewer fat calories.
Back at Burger King, consider this comparison:
Garden salad and dressing
Calories: 330
Fat: 26 g
Sodium: 770 mg
Protein: 6 g
Hamburger (with ketchup, mustard, and pickles)
Calories: 260
Fat: 10 g
Sodium: 490 mg
Protein: 13 g
In every nutritional category listed, the hamburger is healthier than the garden salad, which includes vegetables and presumably would exempt the product from the San Francisco Board of Supervisors' toy promotion ban.
My point is not that hamburgers are generally healthier than salads, but that nutrition is a complicated matter and solving the obesity problem is not as simple as legislating some sort of easy fix. I'm aware of no evidence that parents would stop taking their children to fast food restaurants if only these restaurants wouldn't give out toys with their kids' meals. There just doesn't appear to be any solid scientific basis for this degree of intrusion into the right of companies to market legal products.
The San Francisco Board of Supervisors - which last month voted to ban tobacco sales in all pharmacies -- is, indeed, considering an ordinance which would ban the inclusion of toys in McDonald's Happy Meals, unless the meals include fruits or vegetables and limit the total calories to a specified value.
San Francisco would not be the first local government to take such an action. Last summer, Santa Clara County implemented an ordinance which bans toys from food promotions aimed at children (it only covers unincorporated areas of the county).
In addition, the Center for Science in the Public Interest (CSPI) has threatened to sue McDonald's over its inclusion of toys in Happy Meals.
The San Francisco ordinance would affect not only McDonald's Happy Meals, but any fast food toy giveaways, including Burger King's Kids Meals, which include a toy.
The Rest of the Story
It may come as a surprise to the San Francisco Board of Supervisors, but it is not the toys which are causing childhood obesity, it is the food. If this degree of intrusion into the marketing of legal products is justified, then so is a more direct approach of simply regulating the food that can or cannot be sold to children. Obviously, such an approach is beyond the appropriate role of government.
Moreover, this issue is not as simple as it might appear.
A typical Burger King Kids Meal includes a hamburger, fat free milk, and apple slices, and supplies 430 calories and 10.5 grams of fat.
If instead of a Kids Meal, a parent insisted on his kid having a Garden Salad and fat free milk only, the meal would supply 430 calories and 26 grams of fat.
So the garden salad and fat free milk option provides the exact same number of calories as the Kids Meal. However, the Kids Meal is far healthier, because it supplies only 10.5 grams of fat compared to 26 grams of fat in the garden salad "healthy" meal.
Is the San Francisco Board of Supervisors also going to ban the provision of toys in garden salads sold to children? Why not just ban the sale of garden salads to children, since at Burger King, these salads contain a "whopping" 26 grams of fat.
In fact, a regular hamburger at Burger King is "healthier" than a garden salad. The hamburger has 260 calories and 10 grams of fat, while the garden salad has 330 calories and 26 grams of fat.
At McDonalds, ordering a hamburger provides less fat than ordering a salad with regular dressing (9 grams of fat compared to 15 grams).
If you're worried about sodium intake, a hamburger and a child's Coke at McDonalds provide less sodium than a garden salad and an apple juice box, while providing 50 fewer fat calories.
Back at Burger King, consider this comparison:
Garden salad and dressing
Calories: 330
Fat: 26 g
Sodium: 770 mg
Protein: 6 g
Hamburger (with ketchup, mustard, and pickles)
Calories: 260
Fat: 10 g
Sodium: 490 mg
Protein: 13 g
In every nutritional category listed, the hamburger is healthier than the garden salad, which includes vegetables and presumably would exempt the product from the San Francisco Board of Supervisors' toy promotion ban.
My point is not that hamburgers are generally healthier than salads, but that nutrition is a complicated matter and solving the obesity problem is not as simple as legislating some sort of easy fix. I'm aware of no evidence that parents would stop taking their children to fast food restaurants if only these restaurants wouldn't give out toys with their kids' meals. There just doesn't appear to be any solid scientific basis for this degree of intrusion into the right of companies to market legal products.
Friday, October 01, 2010
FDA Guidelines for Determining Eligibility for Advisory Committees are Ridiculous and Ensure that Conflicts of Interest Will Continue to Plague Agency
Yesterday, I called for the removal of four FDA Tobacco Products Scientific Advisory Committee (TPSAC) panel members - Dr. Neal Benowitz, Dr. Jack Henningfield, Dr. Dorothy Hatsukami, and Dr. Jonathan Samet - because they have significant conflicts of interest with pharmaceutical companies that make it impossible for them to offer objective advice to the Agency on federal tobacco regulatory policy.
A major issue that the panel will soon consider is regulation of dissolvable tobacco products. These are a direct threat to the profits of pharmaceutical companies because they may be used as an alternative for smoking cessation. The threat is so significant that GlaxoSmithKline petitioned the FDA to remove these products from the market.
As I revealed, the rest of the story is that Dr. Henningfield is a GlaxoSmithKline consultant. Clearly, it is unacceptable for Dr. Henningfield to remain on the panel. Similarly, Dr. Benowitz and Dr. Samet should be removed from the panel because they have either consulted for or received grant support from GlaxoSmithKline. Dr. Hatsukami did not receive Glaxo support but did receive funding from another pharmaceutical company to research a nicotine vaccine.
Today, I reveal that the procedure used by the FDA to determine eligibility for participation on advisory panels is severely flawed and essentially guarantees that the Agency will continue to be plagued by conflicts of interest.
Research has shown that FDA advisory committee panelists' conflicts of interest affect their voting behavior. Based on this research, Public Citizen had threatened to sue the FDA to force elimination or remediation of these conflicts (a threat which should be renewed based on the analysis I am about to report).
The Rest of the Story
While the FDA made it look like it was addressing these concerns by adopting new guidelines regarding conflicts of interest in August 2008, an examination of these guidelines reveals that they are woefully inadequate and inappropriate and demonstrate a profound misunderstanding of the problem of conflicts of interest.
A conflict of interest policy should be designed to ensure that decisions regarding federal policy are not influenced by financial conflicts of interest of panel members. The way to do this is to determine what constitutes a disqualifying conflict of interest and then not to allow any scientist with such a conflict to serve on an advisory panel.
Instead of adopting such an approach, the FDA completely copped out by making it look like the Agency was going to disqualify scientists with conflicts of interest, but then giving the Agency the opportunity to nevertheless allow such scientists to serve on the panels.
The FDA guidelines accomplish this in three ways:
1. Waivers
First, the FDA has allotted itself a certain number of waivers. These waivers are essentially free passes, where a conflicted scientist can still be appointed to a panel as long as the the FDA hasn't used up its waiver quota.
While federal law allows the FDA to grant these waivers, the FDA is under no requirement to do so. The FDA has admitted it has created a problem by granting these waivers, but instead of agreeing to eliminate the waivers the FDA has simply agreed to reduce the number of the waivers.
What the FDA apparently fails to understand is that there is no waiver of an otherwise disqualifying conflict of interest. Either an individual has a disqualifying conflict of interest or she does not. If you start making waivers, you are essentially gutting the conflict of interest policy and destroying its entire purpose. You are ensuring that conflicts of interest will continue to plague the Agency's decision-making.
2. Exceptions for Scientific Expertise
The conflict of interest policy goes out the window if the FDA declares that a scientist's potential contribution to an advisory panel outweighs the potential for a conflict of interest. This is obviously an arbitrary or subjective judgment which allows the Agency complete reign to continue allowing conflicted scientists to serve on these advisory panels.
Such a policy is completely ignorant of the purpose of conflict of interest guidelines: to eliminate the formulation of federal policy by conflicted scientists. Every scientist that will be considered for a panel has special scientific expertise and one could always make an argument that his expertise outweighs the potential for a conflict of interest. You see, conflicts of interest are only severe when they actually occur. Looking in advance at a situation, one will never see the tremendous damage that could be done. It is a flawed premise from the start that one can make a judgment, in advance, about how a conflict is going to play out in the future.
Either a conflict of interest is disqualifying or it is not. Either the FDA is committed to ensuring that federal regulatory policy decisions are made by unconflicted scientists or it is not. Putting waivers and subjective judgments of scientific expertise into the procedure has the effect of completely gutting the policy and destroying the very purpose for which the policy exists in the first place.
3. High Threshold for Level of Disqualifying Conflicts of Interest
While some universities set a threshold of $10,000 per year for the amount below which a conflict of interest is not disqualifying, the FDA has set that level at a whopping $50,000. Even a lower threshold has little validity, because there is no evidence that conflicts of interest no longer bias decision-making when the conflict is below a certain amount. But it should be clear to all readers that a conflict at the level of tens of thousands of dollars, even if it does not exceed $50,000 a year, is a huge financial interest.
Let's face it - $49,999 per year is more than most U.S. households make. To be exact, 53% of U.S. households bring in less than $50,000 in income in total. To declare that only above $50,000 a year does a financial interest become disqualifying is insane. It's also insulting, frankly. Are we really to believe that someone who makes $40,000 per year from GlaxoSmithKline consulting is going to nevertheless be completely objective in making a decision that could devastate the company's profits? There is no rational basis for this income threshold and once again, it undermines the entire purpose of the conflict of interest policy.
The End Result? No Effective Conflict of Interest Protection
As we are observing with the Tobacco Products Scientific Advisory Committee - which is a virtual boardroom full of pharmaceutical company (smoking cessation drug) consultants, the FDA's conflict of interest policy is not working. It is essentially no policy at all.
The ineffectiveness of the policy is perhaps best seen by the recent revelation that one of the FDA advisory panel members who voted to keep Avandia on the market without any additional warnings or restrictions was a paid speaker for GlaxoSmithKline, the manufacturer of Avandia. On the same panel, another scientist - this one who voted to remove Avandia from the market - had been a paid speaker for a rival pharmaceutical company which manufactures a competing drug.
It should be noted that these conflicts were on the order of just a few thousands of dollars per year, making the $50,000 limit for disqualifying conflicts of interest a complete joke.
Frankly, the entire policy is a complete joke. It does nothing to prevent the formulation of federal regulatory policy by scientists who have significant financial conflicts of interest.
Seeing how the FDA is not going to remove the conflicted TPSAC panelists, I hope Dr. Benowitz, Dr. Samet, Dr. Hatsukami, and Dr. Henningfield will voluntarily withdraw from the advisory panel due to their clearly disqualifying conflicts of interest. The FDA may be willing to grant them waivers, but these scientists should play no part in promoting the continuing plague of industry influence on federal public health decision-making.
A major issue that the panel will soon consider is regulation of dissolvable tobacco products. These are a direct threat to the profits of pharmaceutical companies because they may be used as an alternative for smoking cessation. The threat is so significant that GlaxoSmithKline petitioned the FDA to remove these products from the market.
As I revealed, the rest of the story is that Dr. Henningfield is a GlaxoSmithKline consultant. Clearly, it is unacceptable for Dr. Henningfield to remain on the panel. Similarly, Dr. Benowitz and Dr. Samet should be removed from the panel because they have either consulted for or received grant support from GlaxoSmithKline. Dr. Hatsukami did not receive Glaxo support but did receive funding from another pharmaceutical company to research a nicotine vaccine.
Today, I reveal that the procedure used by the FDA to determine eligibility for participation on advisory panels is severely flawed and essentially guarantees that the Agency will continue to be plagued by conflicts of interest.
Research has shown that FDA advisory committee panelists' conflicts of interest affect their voting behavior. Based on this research, Public Citizen had threatened to sue the FDA to force elimination or remediation of these conflicts (a threat which should be renewed based on the analysis I am about to report).
The Rest of the Story
While the FDA made it look like it was addressing these concerns by adopting new guidelines regarding conflicts of interest in August 2008, an examination of these guidelines reveals that they are woefully inadequate and inappropriate and demonstrate a profound misunderstanding of the problem of conflicts of interest.
A conflict of interest policy should be designed to ensure that decisions regarding federal policy are not influenced by financial conflicts of interest of panel members. The way to do this is to determine what constitutes a disqualifying conflict of interest and then not to allow any scientist with such a conflict to serve on an advisory panel.
Instead of adopting such an approach, the FDA completely copped out by making it look like the Agency was going to disqualify scientists with conflicts of interest, but then giving the Agency the opportunity to nevertheless allow such scientists to serve on the panels.
The FDA guidelines accomplish this in three ways:
1. Waivers
First, the FDA has allotted itself a certain number of waivers. These waivers are essentially free passes, where a conflicted scientist can still be appointed to a panel as long as the the FDA hasn't used up its waiver quota.
While federal law allows the FDA to grant these waivers, the FDA is under no requirement to do so. The FDA has admitted it has created a problem by granting these waivers, but instead of agreeing to eliminate the waivers the FDA has simply agreed to reduce the number of the waivers.
What the FDA apparently fails to understand is that there is no waiver of an otherwise disqualifying conflict of interest. Either an individual has a disqualifying conflict of interest or she does not. If you start making waivers, you are essentially gutting the conflict of interest policy and destroying its entire purpose. You are ensuring that conflicts of interest will continue to plague the Agency's decision-making.
2. Exceptions for Scientific Expertise
The conflict of interest policy goes out the window if the FDA declares that a scientist's potential contribution to an advisory panel outweighs the potential for a conflict of interest. This is obviously an arbitrary or subjective judgment which allows the Agency complete reign to continue allowing conflicted scientists to serve on these advisory panels.
Such a policy is completely ignorant of the purpose of conflict of interest guidelines: to eliminate the formulation of federal policy by conflicted scientists. Every scientist that will be considered for a panel has special scientific expertise and one could always make an argument that his expertise outweighs the potential for a conflict of interest. You see, conflicts of interest are only severe when they actually occur. Looking in advance at a situation, one will never see the tremendous damage that could be done. It is a flawed premise from the start that one can make a judgment, in advance, about how a conflict is going to play out in the future.
Either a conflict of interest is disqualifying or it is not. Either the FDA is committed to ensuring that federal regulatory policy decisions are made by unconflicted scientists or it is not. Putting waivers and subjective judgments of scientific expertise into the procedure has the effect of completely gutting the policy and destroying the very purpose for which the policy exists in the first place.
3. High Threshold for Level of Disqualifying Conflicts of Interest
While some universities set a threshold of $10,000 per year for the amount below which a conflict of interest is not disqualifying, the FDA has set that level at a whopping $50,000. Even a lower threshold has little validity, because there is no evidence that conflicts of interest no longer bias decision-making when the conflict is below a certain amount. But it should be clear to all readers that a conflict at the level of tens of thousands of dollars, even if it does not exceed $50,000 a year, is a huge financial interest.
Let's face it - $49,999 per year is more than most U.S. households make. To be exact, 53% of U.S. households bring in less than $50,000 in income in total. To declare that only above $50,000 a year does a financial interest become disqualifying is insane. It's also insulting, frankly. Are we really to believe that someone who makes $40,000 per year from GlaxoSmithKline consulting is going to nevertheless be completely objective in making a decision that could devastate the company's profits? There is no rational basis for this income threshold and once again, it undermines the entire purpose of the conflict of interest policy.
The End Result? No Effective Conflict of Interest Protection
As we are observing with the Tobacco Products Scientific Advisory Committee - which is a virtual boardroom full of pharmaceutical company (smoking cessation drug) consultants, the FDA's conflict of interest policy is not working. It is essentially no policy at all.
The ineffectiveness of the policy is perhaps best seen by the recent revelation that one of the FDA advisory panel members who voted to keep Avandia on the market without any additional warnings or restrictions was a paid speaker for GlaxoSmithKline, the manufacturer of Avandia. On the same panel, another scientist - this one who voted to remove Avandia from the market - had been a paid speaker for a rival pharmaceutical company which manufactures a competing drug.
It should be noted that these conflicts were on the order of just a few thousands of dollars per year, making the $50,000 limit for disqualifying conflicts of interest a complete joke.
Frankly, the entire policy is a complete joke. It does nothing to prevent the formulation of federal regulatory policy by scientists who have significant financial conflicts of interest.
Seeing how the FDA is not going to remove the conflicted TPSAC panelists, I hope Dr. Benowitz, Dr. Samet, Dr. Hatsukami, and Dr. Henningfield will voluntarily withdraw from the advisory panel due to their clearly disqualifying conflicts of interest. The FDA may be willing to grant them waivers, but these scientists should play no part in promoting the continuing plague of industry influence on federal public health decision-making.
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