Wednesday, October 31, 2012

CDC Data Show that Rate of Heart Attacks Deaths in Olmsted County, Minnesota Did Not Drop Substantially After Smoking Bans

Yesterday, I discussed a new study published online ahead of print in the journal Archives of Internal Medicine which concluded that smoke-free restaurant and bar ordinances in Olmsted County, Minnesota produced a 34% decline in heart attacks and a 17% decline in sudden cardiac deaths. I pointed out that there was no comparison group, so that one cannot determine whether the observed declines in Olmsted County differ from secular declines that may have occurred elsewhere in Minnesota during the same time period. However, I presented data from the HCUP database which showed that in Minnesota as a whole, there was a 26% decline in heart attacks during the identical time period. This calls into question the validity of the study's conclusion that the decline in heart attacks was due to the smoking ban.

In addition, I pointed out that the observed decline in sudden cardiac deaths was not statistically significant and that the authors appeared to be biased in their dismissing a similarly non-significant 17% increase in sudden cardiac deaths which occurred after the restaurant smoking ban.

Today, I present data from the CDC's National Center on Health Statistics (NCHS) compressed mortality file, which allows to examine heart attack death rates in Olmsted County during the study period.

I thank Dr. Brad Rodu of the University of Louisville for running and sharing these analyses with me.

The Rest of the Story

According to the CDC data, between 1999 and 2001 (prior to the restaurant smoking ban), the age-adjusted rate of heart attack deaths in Olmsted County dropped from 95.9 to 61.8, a decline of 35.6%.

Between 2001 and 2003 (the first two years of implementation of the restaurant smoking ban), the heart attack death rate in Olmsted County declined from 61.8 to 59.4, a decline of 3.9%. Even if one goes out to 2005 to allow a longer time for the death rate to drop, the decline from 2001 is only 24.9%, less than the drop in heart attack rates prior to the restaurant smoking ban.

Thus, these data refute the conclusion that the restaurant smoking ban led to a decline in heart attack death rates in Olmsted County.

Between 2006 and 2009 (the first three years of the bar smoking ban), the heart attack death rate in Olmsted County increased from 35.0 to 41.7, an increase of 19.1%.

Thus, these data refute the conclusion that the bar smoking ban led to a decline in heart attack deaths.

Overall, from 2001 to 2009, the decline in the heart attack death rate in Olmsted County was 32.5%, which is a slower rate of decline than occurred in the pre-smoking ban period of 1999-2001.

Thus, it appears that overall, there was a deceleration of the existing high rate of decline in heart attacks in Olmsted County during the study period. These data provide no evidence that the smoking bans led to a decline in heart attack deaths and therefore cast further doubt on the conclusions of the Annals of Internal Medicine study.

Here is a graph of these data, produced by Dr. Rodu: 

As you can see, the heart attack death rate in Olmsted County was declining rapidly prior to the implementation of the restaurant smoking ban. The rate of decline dropped somewhat after that ban. But after the bar smoking ban, the decline in heart attack death rates actually leveled off. In fact, from 2007 (the year in which the bar smoking law was implemented) to 2009, there was actually a small increase in the heart attack death rate.

The pattern of decline in heart attack deaths in the state of Minnesota as a whole was similar to that in Olmsted County. Thus, my overall impression is that Olmsted County smoking bans probably had no significant impact on heart attack deaths.

The rest of the story is that these data do not support the study's conclusion that the smoking bans in Olmsted County produced a dramatic decline in heart attacks, as the authors of the study concluded.

Again, I have to emphasize that I would like nothing more than to find a dramatic effect of smoking bans on heart attacks in the short-term because I have devoted a substantial portion of my career to promoting smoke-free laws. However, if the data do not support such a conclusion, they don't support such a conclusion and we need to refrain from drawing the conclusion that we favor simply because we want to see that our work is having an effect. I believe that bans on smoking in bars, restaurants, and workplaces, are justified regardless of whether they have an immediate effect on heart attacks. In fact, I would not expect these policies to have dramatic, immediate effects on heart attacks because it takes many years for the atherosclerotic process to occur. So I would not expect to see an impact on heart disease rates until many years following the implementation of these laws. What we would expect to see more rapidly are changes in respiratory disease and respiratory symptoms, as a number of studies have demonstrated.

The danger here is that if we lose our scientific integrity, we lose the public's trust. If we exaggerate or distort the science, we may undermine our public reputation. Once that is lost, it is almost impossible to regain. It seems a shame to sacrifice the public's trust because we want to be able to present more data that is favorable to our cause, even though I believe the cause is a legitimate and important one. In my view, the ends do not justify the means if those means involve sacrificing our scientific integrity.

Tuesday, October 30, 2012

New Study Concludes that Smoking Ban Reduced Heart Attacks and Sudden Cardiac Deaths in Olmsted County, Minnesota

A new study published online ahead of print yesterday in the journal Archives of Internal Medicine concludes that smoke-free restaurant and bar ordinances in Olmsted County, Minnesota produced a 34% decline in heart attacks and a 17% decline in sudden cardiac death. The authors assert that the decline was due to reduced secondhand smoke exposure.

(See: Hurt RD et al. Myocardial infarction and sudden cardiac death in Olmsted County, Minnesota, before and after smoke-free workplace laws. Arch Intern Med 2012; doi: 10.1001/2013.jamainternmed.46).

A smoke-free restaurant law went into effect in Olmsted County on January 1, 2002 and a smoke-free workplace and bar law went into effect on October 1, 2007. The investigators examined age-adjusted rates of myocardial infarction (heart attack) and sudden cardiac death during the 18 months before and after each ordinance.

The results were as follows: "Comparing the 18 months before implementation of the smoke-free restaurant ordinance with the 18 months after implementation of the smoke-free workplace law, the incidence of MI declined by 33% (P < .001), from 150.8 to 100.7 per 100 000 population, and the incidence of sudden cardiac death declined by 17% (P = .13), from 109.1 to 92.0 per 100 000 population."

The paper concludes that these declines are attributable to the smoking bans and that the most likely factor influencing the decreased heart attack and sudden death rates is a reduction in secondhand smoke exposure because of the bar and restaurant smoking bans. According to a Reuters Health article: "The lead researcher on the work said that decline was likely due to less secondhand smoke exposure in restaurants and bars, as smoke can trigger heart problems due to its effects on arteries and blood clotting."

According to the news article, the lead study investigator stated: "There have been lingering doubts among some people about whether or not this was a real finding. We think we have produced the most definitive results that anyone can produce related to smoke-free laws and heart attacks."

The Rest of the Story

There are two major problems with the study that lead me to question the validity of its conclusions.

1. There is no comparison group so we have no idea whether the observations in Olmsted County differ from other counties in Minnesota during the same time period.

The study methodology is flawed, in my view, because it doesn't include any comparison group. While the study demonstrates a decline in heart attacks in Olmsted County during the period 2006-2009, it is entirely possible that similar declines took place in other counties in Minnesota. In other words, from this study design, it is impossible to determine whether the observed decline in heart attacks in Olmsted County represents an effect of the smoke-free bar law or simply reflects a secular change in heart attacks that was occurring anyway during this time period.

It is important to note that during the same time period, heart attack rates were declining rapidly throughout the United States. Major advances in the surgical, medical, and pharmaceutical treatment of heart disease occurred during the study period and were associated with substantial declines in the incidence of heart attacks in may regions of the country.

Although the study does not report heart attack trends in the state of Minnesota as a whole with which we can compare the Olmsted County findings, such data are readily available from the Health Care Utilization Project (HCUP) State Inpatient Database. This database reports trends in hospital cases of myocardial infarction in all hospitals in Minnesota during the period 2001-2010.

Thus, we can compare the observed change in heart attacks in Olmsted County with changes in the entire state of Minnesota. The paper reports a 33% decline in heart attacks in Olmsted County from 2001 to 2009, and concludes that this 33% reduction is due to the smoking ban.

Now, it's time for the rest of the story.

According to the HCUP data, the number of heart attack diagnoses in all Minnesota hospitals declined from 10,626 in 2001 to 7,817 in 2009. This represents a 26% drop in heart attacks.

Thus, the actual finding of this paper is a 33% decline in heart attacks in Olmsted County under secular conditions that saw a 26% decline in heart attacks in the state of Minnesota during the same time period.

Thus, it is clear that the observed 33% reduction in heart attacks in Olmsted County during the study period is not attributable to the smoking ban.

Note that even if one looks only at hospital admissions for heart attacks in Minnesota, there was a 23% decline in these admissions between 2001 and 2006 alone (the data is not provided by HCUP past 2006). However, if one extrapolates to the year 2009 based on the secular rate of decline in the 2001-2006 period, the estimated number of hospital admissions for heart attacks in 2009 represents a drop of 34% from 2001.

In other words, in the absence of a smoking ban, heart attack admissions in Olmsted County would have been expected to drop by 34%. In the presence of the smoking ban, heart attack rates dropped by 33%.

Thus, it appears that the observed decline in heart attacks in Olmsted County is roughly representative of the overall trend in heart attacks in the state as a whole. In this light, the present study hardly supports a conclusion that the Olmsted County smoking bans produced a 33% decline in heart attacks.

If these are "definitive" results, I'd hate to see what "tentative" results look like.

2. The study authors present a heavily biased interpretation of the study findings, questioning the overall objectivity of the analysis.

The authors conclusion that the Olmsted County smoking bans led to a 17% decline in sudden cardiac death is based on their finding that from 2001 to 2009, the rate of sudden cardiac death dropped by 17%. Their conclusion is not based on the finding of a statistically significant drop in sudden cardiac death rates. In fact, they acknowledge that the observed 17% decline was not statistically significant and that they cannot conclude from the analysis that the point estimate is significantly different from zero.

Nevertheless, the authors ignore the lack of statistical significance, writing it off by arguing that had there been a higher sample size, the result would have been statistically significant. They write: "We observed a statistically non-significant decline in the incidence of SCD [sudden cardiac death], which may reflect the relatively smaller number of events in the SCD group. These findings suggest that SHS [secondhand smoke] exposure could be a risk factor for SCD."

OK, fine. Let's accept, for a moment, the authors' explanation that we should ignore the lack of statistical significance of this finding because the sample size was small. (I would argue that since the authors set an a priori significance level, this is not appropriate, but let's ignore that for the time being.)

Now, it turns out that the authors also found, but hide from the readers, that there was a 17% increase in sudden cardiac death rates associated with the implementation of the smoke-free restaurant law in Olmsted County. That's right - from 18 months prior to the smoke-free restaurant law to 18 months after the law, the rate of sudden cardiac death (as reported in Table 2) increased by 17% (the identical amount by which sudden cardiac deaths decreased over the entire study period).

This finding, like the 17% decline in sudden cardiac deaths, was not statistically significant. Curiously, however, the authors do not similarly argue that we can ignore the lack of statistical significance of this finding because of a small sample size.

It appears that statistical significance only matters when the finding in question is an "unfavorable" one. But when the finding is a "favorable" one, then statistical significance can be ignored.

In other words, it is quite clear that the investigators were "hoping" to find an effect of the smoke-free laws on sudden cardiac death and that - although I believe subconsciously - they slanted their interpretation of the data in order to favor such a finding.

I can understand this bias because as a lifelong supporter of smoke-free laws, I would love to see data showing that these laws have an immediate effect in reducing sudden death from heart attacks. But you can see how this kind of bias, which is natural, can affect one's interpretation of the data.

In this case, the investigators are presented with identical findings of a non-significant 17% change in sudden cardiac death rates. In the case where the change is a decline (which they favor), the significance does not matter. In the case where the change is an increase (which they disfavor), the significance absolutely matters and the finding can be completely thrown out as if it doesn't exist.

The rest of the story is that the conclusions of this study are invalid because there was no comparison group and one cannot rule out the possibility that secular declines in heart attacks were occurring in Minnesota during the study period anyway (independent of the Olmsted County smoking laws). In fact, when one examines heart attack incidence rates for the state as a whole, one finds that there were comparable rates of decline in heart attacks in Minnesota during the same time period, nullifying and rendering invalid the study's conclusion. Very clearly, the 33% decline in heart attacks in Olmsted County is not attributable to the smoking ban. A 26%-34% decline in heart attacks would have been expected anyway based on secular trends in the state of Minnesota.

More problematic is the revelation that the interpretation of the study data was biased in the direction of finding an effect of the smoking laws. While understandable because of the passion of advocates who have worked much of their careers to promote smoke-free laws, this bias does ultimately affect the integrity of the science being produced by the tobacco control movement, especially in this area of the smoking ban - heart disease relationship.

Monday, October 29, 2012

Rest of the Story Proposes Corrective Statements on Electronic Cigarettes for the FDA; Health Officials Being Widely Misled by FDA's Prior Statements

According to an article in the Costa Rica News, the Ministry of Health in Costa Rica may ban electronic cigarettes because the U.S. Food and Drug Administration (FDA) has convinced health ministers that these products contain carcinogens and anti-freeze.

According to the article:

"The Ministry of Health is considering banning the import of electronic cigarettes, which are an alternative for those who want to continue smoking without inhaling harmful substances and avoid the smoke nuisance to people who are around. The Ministry of Health, considered that the ban is necessary because the Food and Drug Administration (FDA, for its acronym in English) found that in this type of cigarettes also have cancer-causing substances. ... According to the FDA, when a person inhales, the device ejects nicotine and contains toxic ingredients and chemicals hazardous to health as ethylene glycol, used in antifreeze for vehicles."

The Rest of the Story

It is a shame that the FDA has never corrected the misinformation that has resulted from its July 2009 press conference in which it widely misled the public, falsely scaring the public about the carcinogenic risks associated with electronic cigarette use. It seems clear that this misinformation is leading to health officials in other countries taking action to eliminate these products from the market.

It is inane to remove electronic cigarettes from the market because they contain trace levels of a carcinogen (that is also present in nicotine gum and patches) but to allow cigarettes to remain on the market with their thousand times higher levels of the same carcinogen. Rather than demonstrate a carcinogenic risk associated with vaping, the FDA laboratory study (and subsequent studies by other laboratories) demonstrated just the opposite: that these products greatly reduce the carcinogenic risks inherent in cigarette smoking.

You may recall that as a part of the court order in the Department of Justice's lawsuit against the tobacco companies, the companies are being required to post corrective statements regarding misleading or false assertions that they made to the public.

I believe that the tobacco companies are not the only ones who need to issue corrective statements.

This may be a good time to remind readers of the corrective statement that I have proposed for the FDA:

Proposed Corrective Statement #1: (for the FDA)
Corrective Statement for FDA's Deception Regarding the Presence of Carcinogens in Electronic Cigarettes

We are being required to tell the truth about our laboratory findings regarding the detection of carcinogens in electronic cigarettes. We told you that electronic cigarettes contain carcinogens but we deceived you by not revealing the level and by not comparing it to that of regular cigarettes or nicotine replacement products. Here's the truth:
  • We found only trace levels of tobacco-specific nitrosamines in electronic cigarettes, comparable to those found in FDA-approved nicotine replacement products like nicotine patches and nicotine gum.
  • The levels of carcinogens we detected in electronic cigarettes are orders of magnitude lower than in regular cigarettes, indicating that electronic cigarettes are likely much safer than regular cigarettes in terms of cancer risk.
  • The minute levels of tobacco-specific nitrosamines in electronic cigarettes are a necessary result of the extraction of nicotine from tobacco. Overall, these devices deliver nicotine with only a few other chemicals, compared to the delivery of nicotine plus tens of thousands of chemicals and more than 60 proven carcinogens in regular cigarettes.
Paid for by the Food and Drug Administration by order of The Rest of the Story.

And I would add a second one:

Proposed Corrective Statement #2: (for the FDA)
Corrective Statement for FDA's Deception Regarding the Presence of Anti-Freeze in Electronic Cigarettes

We are being required to tell the truth about our laboratory findings regarding the detection of anti-freeze in electronic cigarettes. We told you that electronic cigarettes contain diethylene glycol, a component of anti-freeze but we deceived you by not revealing that this component was only found in one brand of electronic cigarettes that is no longer on the market and multiple brands of electronic cigarettes that have been subsequently tested have not contained diethylene glycol. Here's the truth:
  • We found diethylene glycol in only one brand of electronic cigarettes which is no longer on the market.
  • Multiple brands of electronic cigarettes that have subsequently been tested have been shown not to contain diethylene glycol.
  • The diethylene glycol most likely results from using low-grade propylene glycol and can be easily controlled by requiring electronic cigarette manufacturers to use pharmaceutical grade propylene glycol. We have not issued any such requirement.
Paid for by the Food and Drug Administration by order of The Rest of the Story.

Friday, October 26, 2012

World Health Organization Urges Countries to Ban Electronic Cigarettes Because Their Use Violates the FCTC Treaty's Recommended Restrictions on Tobacco Advertising

The World Health Organization is urging countries to ban electronic cigarettes because when people use these products, they represent "tobacco advertisements" and this violates the FCTC treaty's recommended restriction on tobacco advertising.

In a 2012 World Health Organization (WHO) report on electronic cigarettes from the Conference of Parties to the Framework Convention on Tobacco Control, WHO states:

"Furthermore, under Article 13.2, Parties have an obligation to undertake a comprehensive ban of all tobacco advertising, promotion and sponsorship. “Tobacco advertising and promotion” is defined in Article 1(c) as “any form of commercial communication, recommendation or action with the aim, effect or likely effect of promoting a tobacco product or tobacco use either directly or indirectly”. Therefore, Parties may also wish to consider whether the sale, advertising, and even the use of electronic cigarettes can be considered as promoting tobacco use, either directly or indirectly. Regardless of whether or not ENDS contain nicotine or tobacco extracts, they are used to mimic smoking, which could be considered as a (direct or indirect) promotion of tobacco use."

The Rest of the Story

This is the fourth installment of complete crap from the World Health Organization in as many days. We end this four-part series on the World Health Organization's opposition to electronic cigarettes with its most ridiculous argument of all: that vaping must be banned because it represents a form of tobacco advertising.

There's just two problems with this argument:

1. Vaping is not tobacco use.

2. Vaping is not advertising. It's vaping.

Moreover, how can the advertising of electronic cigarettes be considered as promoting tobacco use when its very purpose is to get people to switch away from tobacco use? This argument is as inane as asserting that Chantix advertising should be banned because it promotes tobacco use or that advertising for nicotine inhalers should be banned because it is a form of tobacco promotion.

What it really comes down to is that the WHO simply cannot tolerate the fact that something which looks like smoking could possibly be a good thing, even if it is saving thousands of lives. And so once again, it becomes clear that the WHO's primary concern is not health, but ideology.

Thursday, October 25, 2012

World Health Organization Urges Countries to Ban Electronic Cigarettes Because They Could Increase Secondhand Smoke Exposure

The World Health Organization is urging countries to ban electronic cigarettes because, it argues, their use could increase secondhand smoke exposure, as some might claim that these devices do not contain tobacco and do not produce smoke.

In a 2012 World Health Organization (WHO) report on electronic cigarettes from the Conference of Parties to the Framework Convention on Tobacco Control, WHO states:

"the use of ENDS could hamper the implementation of Article 8 (Protection from exposure to tobacco smoke) as ENDS users in public places may claim that their electronic cigarette does not contain tobacco and/or does not produce second-hand tobacco smoke."

The Rest of the Story

This would be a valid argument if electronic cigarettes produced tobacco smoke and users were lying in claiming that these products do not produce secondhand smoke.

But the truth is that electronic cigarettes do not contain tobacco and do not produce secondhand smoke! Thus, it is the World Health Organization - not electronic cigarette users - who are hampering the implementation of Article 8 of the Framework Convention on Tobacco Control.

Because they do not produce secondhand smoke and involve no combustion of tobacco, the use of electronic cigarettes actually greatly reduces, rather than increases public exposure to secondhand smoke. Every electronic cigarette used represents that much less secondhand smoke that is produced. In fact, one of the major advantages of electronic cigarettes is that they do not produce secondhand smoke, and thus they benefit not only the user, but also the people who might otherwise be exposed to that person's cigarette smoke.

As Drs. Ted Wagener and Belinda Borrelli and I argue in an article in the journal Addiction: "an often unconsidered advantage of e-cigarettes is that they do not require combustion and therefore produce no second-hand smoke exposure (SHSe) to the user or to individuals in the smoker's environment. Second-hand smoke, especially in homes with children, poses a serious public health risk increasing the incidence of sudden infant death syndrome, respiratory illness, middle-ear disease and asthma. Children aged between 3 and 11 years have the highest levels of SHSe, probably because they spend a majority of their time in close proximity to a caregiver who smokes. Despite the strong national effort of introducing smoking bans in public spaces, children living with smokers have not experienced any reduction in their SHSe, as evidenced by serum cotinine levels. Furthermore, clinical interventions aimed at reducing children's SHSe by targeting caregiver smoking behavior (i.e. cessation and/or smoking outside) often fail to produce long-term cessation and result in minimal to no reduction in SHSe for children, as measured by objective indicators such as urinary or serum cotinine or a child-worn passive smoke monitor. A significant majority of parents return to smoking or do not maintain consistently smoke-free homes. As such, the current methods of reducing caregiver smoking behavior cannot be relied upon as the sole means of reducing children's SHSe. The use of e-cigarettes by caregivers who smoke and who are unable or unwilling to quit smoking by more traditional means may be a viable alternative method to reduce children's SHSe."

Thus, far from increasing secondhand smoke exposure, the use of electronic cigarettes will greatly reduce such exposure, especially in settings such as the household where parents who switch to electronic cigarettes will be able to greatly reduce their children's exposure to secondhand smoke.

The rest of the story is that it is the World Health Organization, not electronic cigarette users, who are undermining and hampering the implementation of Article 8 of FCTC and thus contributing towards an increase in population exposure to secondhand smoke and its associated hazards.

Wednesday, October 24, 2012

World Health Organization Urges Countries to Ban Electronic Cigarettes Because if They are Not Banned, Smokers Might Use Them

The World Health Organization is urging countries to ban electronic cigarettes, rather than merely regulate them, because if not banned, smokers may use these products in attempts to quit smoking.

In a 2012 World Health Organization (WHO) report on electronic cigarettes from the Conference of Parties to the Framework Convention on Tobacco Control, WHO states:

"Parties may wish to consider that as ENDS [electronic cigarettes] are new products resembling tobacco products that would maintain a nicotine addiction, regulating them rather than banning them could grant these new products a level of legitimacy in terms of market access, even though they may be subject to the provisions of the WHO FCTC or to regulation as medical products. Parties may wish to consider that admitting such new products would not support the objective of the WHO FCTC as stated in Article 3, which is to “… reduce continually and substantially the prevalence of tobacco use …”."

The Rest of the Story

This is the second serving of complete crap from the World Health Organization in two days. Yesterday, I revealed that the WHO is urging countries to ban electronic cigarettes because their use normalizes smoking. I showed how ridiculous that statement is because it is smoking that normalizes smoking, not quitting smoking.

Today, I expose the WHO's recommendation that countries ban electronic cigarettes because if not banned, smokers might actually use these products to try to quit smoking and that would lead to an increase in smoking.

This is the stupidest and most convoluted argument I have heard from the World Health Organization since yesterday.

How could quitting smoking or reducing the amount of cigarette consumption using electronic cigarettes increase the prevalence of tobacco use? This would only be the case if either: (1) youth were using electronic cigarettes and then switching to real ones; or (2) smokers who would otherwise have quit are using electronic cigarettes, but not as complete substitutes for smoking.

There is absolutely no evidence to support either contention. First, there is no evidence that electronic cigarettes are becoming popular among youth or that a single nonsmoking youth has ever become addicted to smoking because he or she started using electronic cigarettes.

Second, there is no evidence that smokers who would otherwise have quit smoking completely are using electronic cigarettes as an alternative to quitting. In fact, there is strong evidence that the opposite is true. The majority of electronic cigarette users are smokers who have been unable to quit via other means - including the NRT and other drugs that the WHO recommends in lieu of electronic cigarettes.

The truth is that even among smokers who are unmotivated to quit, 54% of those who tried electronic cigarettes either quit or cut down on their cigarette consumption by more than one half. Thus, the World Health Organization's argument is fallacious. The use of electronic cigarettes clearly results in a reduction in smoking. How could the WHO argue that making electronic cigarettes available is going to increase smoking.

Clearly, the WHO is not interested in objectively viewing the scientific evidence. I don't even think the WHO is interested in subjectively viewing the scientific evidence. It appears that they simply don't care about the scientific evidence at all.

For the WHO, it is all about ideology, not about scientific evidence or actual effects on health.

While in theory, some sort of international tobacco control treaty could be effective in reducing the burden of tobacco-related morbidity and mortality, I am becoming afraid that in the hands of the World Health Organization, such a treaty is unworkable because the WHO is more interested in promoting ideology than health.

Not only do I now believe that the continued implementation of FCTC under the auspices of the WHO could be detrimental rather than helpful to the public's health, but I am convinced that the WHO has already caused substantial public health damage.

Tuesday, October 23, 2012

World Health Organization Urges Countries to Ban Electronic Cigarettes Because They "Normalize" Smoking

In a 2012 World Health Organization (WHO) report on electronic cigarettes from the Conference of Parties to the Framework Convention on Tobacco Control, WHO is urging countries to ban these products because they "normalize" smoking. 

According to the report: "ENDS [electronic cigarettes] are products resembling cigarettes and could therefore undermine the denormalization of tobacco use upheld by the WHO FCTC. One of the guiding principles of the guidelines for implementation of Article 12 (Education, communication, training and public awareness) is Norm change. It stipulates that it is “essential to change social, environmental and cultural norms and perceptions regarding the acceptability of the consumption of tobacco products, exposure to tobacco smoke ...”. Parties are therefore invited to consider that a ban of ENDS as already undertaken by some Parties would contribute to changing the social norms regarding the consumption of tobacco products."

It should be noted that the WHO's advice on electronic cigarettes has a significant influence on many countries' regulatory decisions on electronic cigarettes. For example, Qatar recently announced a ban on electronic cigarettes and cited the WHO's recommendations as a major factor in its decision.

The Rest of the Story

The World Health Organization is arguing that electronic cigarettes should be banned because their use "normalizes" smoking and that a ban on these products would result in the "de-normalization" of smoking.

What a bunch of crap.

What does the World Health Organization think that smokers who are using electronic cigarettes are going to do if these products are taken off the market? Quit smoking? Not likely. The truth is that if taken off the market, most ex-smokers who have quit by using electronic cigarettes are going to return to cigarette smoking. Thus, a ban on these products will not have any effect on reducing smoking and therefore will not contribute in any way to the de-normalization of smoking.

Moreover, smokers who are using electronic cigarettes are typically those who are unable to quit. If not for electronic cigarettes, they would be smoking, not ex-smokers. Thus, the use of electronic cigarettes plays no role in normalizing smoking behavior. On the contrary, it helps many smokers get off of cigarettes and thus reduces smoking prevalence.

What the World Health Organization is saying is that electronic cigarette use is unacceptable because it "looks like" smoking. The WHO is willing to let this ideological obsession outweigh the tremendous potential for public health benefits and the saving of lives that electronic cigarettes offer.

In other words, the World Health Organization is telling countries that it is more important to discourage any behavior that looks like smoking than it is to save the lives of smokers. Better that smokers should die than that they should adopt a behavior that looks like smoking, even though that behavior may well save their lives.

This is such a dreadful and irresponsible position that it leads me to question whether the Framework Convention on Tobacco Control may end up doing more harm than good. If this is what FCTC is all about, then I'm not convinced that its adoption is going to end up benefiting the public's health.

By its position on electronic cigarettes, the World "Health" Organization is sacrificing health for the sake of a narrow ideology. Its "quit or die" attitude for smokers demonstrates a callous disregard for the lives and health of smokers. The lives and health of smokers are apparently not very important to WHO because those lives can be sacrificed for the principle that there is nothing worse than a behavior that mimics smoking.

Of course, what the WHO fails to recognize is that the fact that vaping mimics smoking is precisely the reason why electronic cigarettes are such a promising strategy for smoking cessation. They are the first product in history that addresses both the pharmacologic and the behavioral aspects of smoking addiction.

The rest of the story is that the World Health Organization is not only making a completely fallacious argument by suggesting that electronic cigarettes normalize smoking. The WHO is also demonstrating that it has lost its vision of its health mission and is now willing to sacrifice the lives of smokers for the sake of an ill-conceived ideology.

Monday, October 22, 2012

Comprehensive Review of Effectiveness of Intensive Behavioral Intervention and Pharmacotherapy for Smoking Cessation Finds an 87.5% Failure Rate, But Fails to Report or Comment on This Result

In a comprehensive review of the effectiveness of combined pharmacotherapy and intensive behavioral intervention for smoking cessation published as a Cochrane review, the authors report that the combination of nicotine replacement therapy (NRT) or other smoking cessation drugs and behavioral counseling or support is twice as effective for smoking cessation as usual care, in which there is only a brief cessation component but no other behavioral support and no medication.

(See: Stead LF, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. The Cochrane Library 2012, Issue 10.)

The methods and results of the study are summarized as follows:

Objectives: "To assess the effect of combining behavioural support and medication to aid smoking cessation, compared to a minimal intervention or usual care, and to identify whether there are different effects depending on characteristics of the treatment setting, intervention, population treated, or take-up of treatment."

Search methods: "We searched the Cochrane Tobacco Addiction Group Specialised Register in July 2012 for records with any mention of pharmacotherapy, including any type of NRT, bupropion, nortriptyline or varenicline."

Selection criteria: "Randomized or quasi-randomized controlled trials evaluating combinations of pharmacotherapy and behavioural support for smoking cessation, compared to a control receiving usual care or brief advice or less intensive behavioural support. We excluded trials recruiting only pregnant women, trials recruiting only adolescents, and trials with less than six months follow-up."

Results: "Forty-one studies with a total of more than 20,000 participants met the inclusion criteria. ... Most studies provided NRT. ... One large study (the Lung Health Study) contributed heterogeneity due to a substantially larger treatment effect than seen in other studies (RR 3.88, 95% CI 3.35 to 4.50). Since this study used a particularly intensive intervention which included extended availability of nicotine gum, multiple group sessions and long term maintenance and recycling contacts, the results may not be comparable with the interventions used in other studies, and hence it was not pooled in other analyses. Based on the remaining 40 studies (15,021 participants) there was good evidence for a benefit of combination pharmacotherapy and behavioural treatment compared to usual care or brief advice or less intensive behavioural support (RR 1.82, 95% CI 1.66 to 2.00) ... ."

The study concludes: "Interventions that combine pharmacotherapy and behavioural support increase smoking cessation success compared to a minimal intervention or usual care. ... clinicians should encourage smokers to use both types of aid."

The Rest of the Story

Despite the length and comprehensiveness of this review, published in the reputable Cochrane Library, there is one piece of critical information that was omitted from the review. In fact, I would argue that it is the single most important piece of information that readers need to know.

What the article fails to reveal to the reader is the answer to the most basic and vital question of all:

What was the average success rate for combined pharmacotherapy and behavioral support?

Believe it or not, the answer is not found in the text of the paper. In fact, to derive the answer, I had to do the calculations myself.

I included only studies in which smoking cessation was biochemically validated because it is widely recognized that smokers over-report true cessation rates in studies like these.

It turns out that if you pool all the studies in which smoking cessation was biochemically validated (27 of the 40 studies), the overall success rate for combined pharmacotherapy and behavioral support (the best of the best of what is currently available and sanctioned by the public health establishment) is only 12.5%.

Put another way, the treatment that this review recommends for all patients and about which the review boasts has a dismal 87.5% failure rate.

It seems to me that any conclusion other than that this treatment was not very effective is a biased one that does not do justice to the scientific integrity of the reporting of the research findings.

And to completely hide the fact that the approach was found to have an 87.5% failure rate seems to me to demonstrate an immense bias in favor of this strategy. Why would the article fail to even mention to the reader that the intervention actually failed for more than 87 of every 100 smokers?

Sure, the fact that the intervention was twice as effective as usual care is technically correct, but it hardly gives the reader and the public an accurate sense of the value of the intervention as a population-based approach to smoking cessation.

This story illustrates the way in which the anti-smoking movement has been systematically distorting the presentation of the science in order to create the false perception that Big Pharma-produced drugs are an effective strategy for smoking cessation. Usually, this deception of the public is associated with researchers or groups that have financial conflicts of interest with Big Pharma. In the present case, these are non-conflicted researchers who apparently have been so brainwashed by the workings of the anti-smoking movement that they can write pages and pages of text without providing the single most important result that is most critical to the review.

The rest of the story is that this review confirms what I have previously argued: the scientific evidence demonstrates that smoking cessation drugs, even when combined with intense behavioral support - are dismally effective for smoking cessation. They fail about 90% of the time. And this is under the most advantageous situation, in which the drugs are being used as part of a closely monitored research study. In "real-life" situations, these drugs are even less effective.

But the anti-smoking movement doesn't want you - the public - to know this fact because it would threaten its huge financial windfall that it receives from the pharmaceutical companies.

Ironically, while the best of the best in terms of NRT and behavioral support is now known to succeed in only about 12.5% of cases, electronic cigarettes were found to result in a six-month cessation rate of 22.5% among unmotivated smokers. Yet NRT continues to be the favored approach by anti-smoking researchers, anti-smoking groups, and federal health agencies including the FDA, while electronic cigarette use is heavily discouraged.

Friday, October 19, 2012

Federal Government Wastes $10 Million on Nicotine Vaccine Studies; Money Would Have Been Better Spent Investigating Potential Role of Electronic Cigarettes

In 2009, the federal government awarded Nabi Pharmaceuticals a $10 million stimulus grant to conduct a clinical trial of NicVax, an injectable vaccination intended to help people quit smoking.

According to an NIH press release: "Successful completion of the study will bring the vaccine closer to final approval. Already given fast track designation by the U.S. Food and Drug Administration, NicVAX passed initial regulatory hurdles showing the basic idea is sound. Patients in the trial get six monthly shots in the arm. ... The award continues a public-private partnership between NIDA and NABI that started in 2001 with a grant to support the basic science that led to NicVAX. The effort continued in 2005 with a grant to help support early clinical trials to test the safety and efficacy of the vaccine."

At the time, the director of the National Institute on Drug Abuse (NIDA) predicted that the nicotine vaccine would be a powerful tool to promote smoking cessation: "A vaccine that limits the ability of nicotine to enter the brain, and that is effective for six to 12 months following vaccination will give smokers a fighting chance to end the addiction/relapse cycle that plagues the great majority of smokers trying to quit."

For several years, I have been arguing that the tobacco control movement's obsession with nicotine as the sole element involved in smoking addiction has been problematic and has hindered the search for a truly effective tool to promote smoking cessation. I have repeatedly pointed out that smoking addiction involves far more than just nicotine. There are many other aspects to the addiction, including physical stimuli, behavioral aspects, and even social aspects. The hand motions, blowing of smoke, holding of the cigarette, and many other physical, behavioral, and social stimuli serve as reinforcements of the overall smoking experience. A sole focus on just nicotine is not an effective strategy for finding a workable strategy.
I have also pointed out that for the first time, we now have a tool that does address the behavioral aspects of the addiction, not just the pharmacologic aspects. That tool is called the electronic cigarette. Because it looks like, feels like, and is used like a cigarette, in addition to supplying nicotine, the electronic cigarette addresses all aspects of the smoking addiction. It simulates the smoking experience. That is precisely why it has been helpful to so many smokers in quitting and why the product's use has been growing exponentially.

The Rest of the Story

As I predicted, the nicotine vaccine turned out to be a dismal failure. Yesterday, Nabi Pharmaceuticals reported the results of a phase II clinical trial in which the nicotine vaccine in combination with Chantix was found to be no more effective than Chantix alone: "Smokers who received both products quit smoking at the same rate as those treated with a placebo and varenicline, according to an initial evaluation of the study's data, Nabi reported. Those rates were similar to those involving smokers in other studies who had received only varenicline".

These results come on the heels of the revelation that the phase III clinical trial funded by the federal government was a complete failure: "the primary end point was not met and there was no statistical difference between the NicVAX and Placebo groups. As in previous trials, NicVAX was well-tolerated with a clinically acceptable safety and tolerability profile. These results are not different from the results of the first Phase III trial that were reported in July 2011, which had a similar design and protocol."

In  my opinion, the federal government put its eggs in the wrong basket. At the same time that the federal government was spending $10 million on the nicotine vaccine, it was engaging in a campaign to discourage smokers from using electronic cigarettes to quit - scaring them by grossly exaggerating information about trace levels of carcinogens detected in these products and trying to convince them that all electronic cigarettes may have anti-freeze in them.

So while the FDA gave "fast track" status to a drug that I believe was clearly doomed to failure, it essentially tried to pull off the market a new device which is perhaps the most promising innovation ever developed to treat not just nicotine addiction, but the smoking addiction as a whole.

To make matters worse, the anti-smoking researchers who had put their own eggs in the nicotine vaccine basket - showing poor judgment in their ability to evaluate the most promising strategies for smoking cessation because of their history of Big Pharma funding - were given prominent positions guiding federal smoking cessation strategy.

For example, the panel chair of the Joint Commission panel which established hospital standards for the treatment of smoking cessation was Dr. Michael Fiore. However, Dr. Fiore was receiving grant funding from Nabi Pharmaceuticals, whose nicotine vaccine had been given fast track status by the FDA "for use as a therapeutic for smoking cessation.'"

Clearly, it would have been to Nabi Pharmaceutical's great financial interest to have in place as it begins to market this drug a hospital standard requiring all smokers to be prescribed at discharge an FDA-approved smoking cessation drug. This is precisely the requirement that Dr. Fiore and his panel established.

In my opinion, it was inappropriate for Dr. Fiore to have accepted the position as chair of this panel, given his financial conflict of interest. The recommendations from the panel were clearly biased because of this financial conflict.

Another example is the appointment of not one, but two Nabi Pharmaceuticals-conflicted scientists as members of the Tobacco Products Scientific Advisory Board (TPSAC).  Dr. Neal Benowitz has consulted for Nabi Pharmaceuticals and Dr. Dorothy Hatsukami has received grant support from Nabi Pharmaceuticals for investigation of the effectiveness of NicVax.

Are these conflicted scientists really the ones we want on a panel that is supposed to be making objective, big picture recommendations on the best strategies to reduce smoking-related morbidity and mortality? NIH advisory panels are not supposed to have members with financial conflicts of interest in the first place. Why this special exception for the tobacco products advisory panel?

The rest of the story is that the detrimental effects of the financial relationships between Big Pharma and many of the leading scientists in the anti-smoking movement as well as with the federal government itself are now starting to show. The taxpayer money spent on the nicotine vaccine was a waste of money as I predicted before the trial had even begun. The bias towards a narrow "nicotine only" strategy for smoking cessation has inundated the FDA and the NIH, which has actually partnered with Big Pharma to waste taxpayer money on a strategy that was doomed to failure from the start. And now, a scientist who put her eggs in the wrong basket as well is serving as a member of a national advisory panel to the FDA on tobacco products. In the mean time, the FDA has done everything but place a formal ban on electronic cigarettes, the one product which shows promise because of its ability to address both the pharmacologic and behavioral aspects of smoking addiction.

Thursday, October 18, 2012

San Rafael Bans Smoking on Downtown Sidewalks Unless Smokers are Walking with Purpose

According to an NBC News article, the city of San Rafael (California) has passed an ordinance that bans smoking in all downtown areas unless the smoker is walking with purpose.

Specifically, according to the article: "The ordinance ... makes it illegal to smoke outside in downtown San Rafael, a quaint and affluent city in Marin County, except when the smoker is 'actively passing on the way to another destination.'"

The ordinance states that smoking is prohibited on "sidewalks and other pedestrian areas and public places in Downtown San Rafael accessible to the general public, except while actively passing on the way to another destination. For the purposes of this section, Downtown San Rafael means the area defined by Hetherton Street between Mission Avenue and Second Street, Second Street between Hetherton and the beginning of Miracle Mile, Fourth Street from the beginning of the Miracle Mile to H Street, H Street between Fourth Avenue and Mission Avenue, and Mission Avenue between H Street and Hetherton Street. This prohibition applies to sidewalks along public and private streets, pedestrian alleys, walkways providing access from parking lots and structures to stores or sidewalks, and all other pedestrian paths or areas that are accessible to the general public within and around the perimeter of the area defined ... above."

The Rest of the Story

Now how exactly do they define "another destination?"

Suppose that I am pacing back and forth on the sidewalk between point A and point B. Am I actively passing on the way to another destination? If a cop confronts me and issues me a ticket, I am going to argue that I am in compliance with the ordinance. After all, point A is a "different destination" than point B, is it not? How far does point A have to be from point B to count as a "different destination?" What if it is only one foot from point B and I am merely stepping back and forth?

Well, then, maybe it depends on your interpretation of the phrase "actively passing."

If I am meandering down the street from point C to point D, is that "actively" passing or "passively" passing? What if someone is pushing me? Is that considered passive movement, as opposed to active movement, which would be if I were walking unaided? What is someone is pushing me in a wheelchair? Is that active movement or passive movement? 

What if I stop for a moment to figure out where I am going? Can I be served a citation the moment I stop? What if I am a forgetful person and I have trouble remembering where I am supposed to be going? How long a grace period do you get before you need to make up your mind what your destination is or how to get there?

Now a rather complex enforcement issue is whether or not the purpose with which the smoker is walking matters. For example, what if the sole purpose of the smoker walking is to avoid being served with a citation? Assume that the smoker is passing from point E to point F but has no real desire to go to point F. Is the smoker violating the spirit of the law? Is he skirting the law? Should the cops reason that although he is technically in compliance, his purpose was to violate the law and so he can be given a citation?

Importantly, the law states that in order to be smoking lawfully, you need to be "passing" between destinations. Does that mean that you can be served a citation the moment you arrive at your destination? Can the police follow you, waiting until you arrive at your destination, and then give you a ticket if your destination is within the defined downtown area? And if you are pacing between points G and H, can the cops ticket you the moment you arrive at point H? Can you successfully argue that point H is merely a resting point, and that your actual destination was point I? Thus, you were actively passing between point G and point I, and it only looked like point H was your destination.

Finally, we have the age-old question: What if the smoker is walking in a circle? Does the circle have a beginning? Or an end? Can't the smoker argue that as long as he is walking in a circle, he continues to be actively passing on the way to a destination, because the circle is unending and he can smoke for as long as he wants because he will never reach his destination? Or can the cops argue that he reached his destination the moment he completed walking one circumference? But who are the police to define where a circle begins ... or where it ends?

Wednesday, October 17, 2012

Researchers at UCLA to Study the Potential Effects of Fourthhand and Fifthhand Smoke on Asthma Development

According to this article, researchers at UCLA are embarking on a $377,220 NIH-funded study to examine the potential effects of fourthhand and fifthhand tobacco smoke.

What is fourthhand smoke, you ask?

I coined the term to represent the effects that fetal exposure to tobacco smoke might have on the subsequent child's children, even though those individuals might have no exposure to firsthand, secondhand, or thirdhand smoke.

What, then, is fifthhand smoke?

I coined the term fifthhand smoke to represent the effects that fetal exposure to tobacco smoke might have on the subsequent child's grandchildren.

Sound farfetched? Is it difficult to imagine a biological mechanism by which fetal exposure to tobacco smoke could cause asthma in a child that has not yet even been conceived, or in the grandchildren of the fetus?

The Rest of the Story

This is precisely what the UCLA researchers are hypothesizing to be the case. The study aims to investigate the potential effects of fourthhand and fifthhand smoke on asthma incidence one and two generations removed from the exposed fetus.

According to the article: "Virender Rehan, M.D., principal investigator at The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed), focuses on understanding the detrimental effects of maternal smoking, not only on the exposed offspring but also on the many generations that follow. More specifically, the proposed study will determine if the risk of childhood asthma induced following exposure to cigarette smoke during pregnancy is limited only to the offspring of the exposed pregnancy, or if this risk is carried to grandchildren or even great-grandchildren. “While it is widely known that maternal smoking can pose problems for an unborn child, including asthma, this study is important in that it sheds light on the depth of the issue and raises concerns about the effects of smoke exposure during pregnancy on subsequent generations,” said Dr. Rehan. Studies have shown that exposure to nicotine in utero affects lung growth and differentiation by altering specific mechanisms that are necessary for fetal lung development, which often results in an offspring’s predisposition to asthma."

A study published in 2005 in the journal Chest found that children whose grandmothers smoked during their mother's pregnancy with them were more likely to develop asthma, even after controlling for their own mother's history of asthma and for their own in utero exposure to tobacco smoke. This has led some to speculate that in utero tobacco smoke exposure may have a transgenerational effect on asthma incidence. The hypothesis is that in utero exposure to tobacco smoke could affect generations of offspring down the road through epigenetic mechanisms. Specifically, the authors of the Chest article hypothesize as follows:

"It is possible that by altering DNA methylation patterns in the fetal oocytes, tobacco-derived products may affect both immune function and xenobiotic detoxification mechanisms in the offspring, resulting in an increased susceptibility to asthma affecting one generation to the next." 

Epigenetics refers to changes in gene expression that can be passed on to subsequent generations but which are not the result of actual changes to the DNA sequencing in the genes (as are mutations, for example). Instead, epigenetic changes may involve DNA methylation and histone modifications, which are capable of affecting gene expression (though not technically changing the genes themselves). 

So if you thought that thirdhand smoke was a stretch, get ready for what I'm sure will be a slew of studies on fourthhand and fifthhand smoke. The emergence of the field of epigenetics has opened the door to the possibility that tobacco smoke exposure now could have effects on generations to come. This could be a field day for the anti-smoking movement.

What's not clear to me, however, is why all of this matters. How is it going to affect public health practice or policy? It seems to me that the results of the research do not matter. If the study finds that smoke exposure has transgenerational effects, then what we need to do is develop and deliver more effective interventions to reduce smoking during pregnancy. If the study finds, instead, that smoke exposure does not have transgenerational effects, then what we need  to do is develop and deliver more effective interventions to reduce smoking during pregnancy. Shouldn't the money be going into the development and delivery of interventions to reduce smoking during pregnancy, rather than into studying the methylation patterns of fetal oocytes?

Tuesday, October 16, 2012

IN MY VIEW: CDC's Partnership with Company that Contaminated Much of Nation's Rice Supply with Arsenic is Inexcusable and Needs to End Immediately

The nation's leading prevention agency is partnering with a company that has contaminated much of the nation's rice supply with inorganic arsenic, a proven human carcinogen which not only causes cancer but can cause neurological problems in children.

The Centers for Disease Control and Prevention has forged a partnership with Pfizer, the maker of Roxarsone - the drug containing arsenic which was fed to chickens whose litter ended up being used as fertilizer in rice fields in much of the southern U.S. As a result of this contamination, a substantial portion of the nation's rice supply contains potentially dangerous levels of arsenic.

Although Pfizer agreed to stop U.S. sale of Roxarsone after an FDA investigation and subsequent report revealed high levels of inorganic arsenic in chickens, the company is apparently still selling the product abroad and has opposed state legislation that would ban the sale of arsenic-containing drugs.

Moreover, there is evidence that the problem of inorganic arsenic contamination caused by Roxarsone was widely understood years prior to the company's action. The European Union banned the use of the drug way back in 1999 and even Tyson - the U.S. poultry giant - stopped using the drug in 2004.

Late in 2011, I revealed that according to a CDC Foundation press release, the CDC Foundation, the CDC, and Pfizer have formed a partnership, made possible by Pfizer funding, to conduct a study examining the economic impact of smoke-free bar and restaurant laws in nine states.

In addition: "The CDC Experience Applied Epidemiology Fellowship is made possible by a public/private partnership supported by a grant to the CDC Foundation from External Medical Affairs, Pfizer Inc."

The CDC is also partnering with Pfizer to study hemophilia.

The CDC's partnership with Pfizer goes much deeper than this. Pfizer boasts: "All of us at Pfizer are proud to be partners with CDC and the CDC Foundation in protecting and strengthening health throughout America and around the world. Our nearly 15-year history of partnership, spanning a dozen projects, has helped CDC train more of the world’s best epidemiologists, explore the effects of landmark public health policies, and advance disease prevention and treatment efforts. CDC and CDC Foundation are true in their desire to attack health problems from new perspectives and to share information and expertise in the search for better health, right now."

The Rest of the Story

It may be true that Pfizer is true in its desire to attach health problems and to share information in the search for better health, but not when it comes to the health dangers of its own products, where its profits may be threatened. 

Far from sharing information with the public and attacking health problems, Pfizer's definitive action did not come until 12 years after the European Union acted and 8 years after Tyson acted before it finally was caught red-handed by the FDA and forced to "voluntarily" withdraw its arsenic-laced drug from the U.S. market.

One might argue that the company simply didn't know that its organic arsenic-containing drug resulted in inorganic arsenic contamination of chickens and chicken litter. This is not a tenable explanation, however. According to an article by Tom Philpott: 

"by 2004, a Chemical Engineering News article shows, a USDA researcher was concerned enough to examine technical data kept by roxarsone producer Alpharma (later acquired by Pfizer). What she found was alarming: Roxarsone-treated chicken has "three to four times greater than [inorganic] arsenic levels in other types of poultry and meat from other animals"—levels that for heavy chicken eaters, would be "greater than the tolerable daily intake recommended by the World Health Organization."

This information was enough to get the company to withdraw Roxarsone from the U.S. market in 2011 when threatened by the FDA, but when it acquired the company earlier in the year, it was apparently not interested enough in "attacking health problems from new perspectives" to cease the sales of a drug that it presumably knew was causing inorganic arsenic contamination of chickens and poultry litter.

Keep in mind, also, that Congressional legislation had been introduced back in 2009 which would have banned Roxarsone because of concerns over inorganic arsenic contamination of chickens. 

But the story doesn't end here.

What makes matters worse, and what makes it completely unacceptable for the CDC to partnering with Pfizer, is that despite what it now knows about the dangers of Roxarsone, the company is apparently still selling the product in some countries outside the U.S., at least according to Force Change.

According to its petition urging the company to halt its international sales of Roxarsone: "In 2011, the FDA announced findings of higher levels of inorganic arsenic in the livers of chickens treated with the feed additive Roxarsone than in the livers of untreated control chickens.  The manufacturer Pfizer agreed to pull all of its supply from U.S. shelves, but decided to keep selling the product internationally. Inorganic arsenic is a known carcinogen, and if it’s not safe enough for American consumers, it is not safe enough for consumers worldwide." ...

"Both humans and animals are eating chicken meat contaminated with arsenic, possibly risking their health and well-being.  Arsenic excreted by the chickens also poses a major health and environmental threat; feces runoff from chicken farms and fertilizer made from chicken waste may be polluting groundwater, lakes, oceans and other bodies of water."

"The FDA study findings found that Roxarsone-treated birds were found to have more than 800 times more total arsenic in their livers and 14 times more total arsenic in their meat than untreated birds.  Roxarsone-treated birds had 300 times more total arsenic in their livers and and ninefold more in their meat even after a 5 day washout period. The study also found that some Roxarsone treated birds tested fairly high for arsenic levels at 2,900 parts per billion, far exceeding the FDA tolerance level of 2,000 parts per billion.  Alpharma LLC, a subsidiary of Pfizer, voluntarily pulled Roxarsone off of U.S. shelves after the findings and should be applauded for this move. However, they are continuing to sell this product abroad, currently carrying in approximately 12 countries. ... Pfizer needs to protect all consumers, not just Americans. All human beings deserve to be protected in important issues such as the food supply. Our global neighbors should be able to trust American products and American companies, knowing that they have their best interests as heart.  Knowingly selling an additive that is tainting the food supply and damaging the environment is unconscionable and sends out a horrible message of indifference and greed."

Equally unconscionable is for a national public health agency to partner with that very company which is knowingly selling an additive that is tainting the food supply and damaging the environment.

The rest of the story is that CDC's continued willingness to partner with Pfizer under these conditions sends out a horrible message of indifference and greed.

Monday, October 15, 2012

How Can Anti-Smoking Groups Defend Accepting Money from a Company that Has Apparently Poisoned our Children with Arsenic?

As I have revealed on this blog, the financial ties between Pfizer and the anti-smoking movement run deep.

The numbers compiled by The Rest of the Story reveal that during 2011 and the first two quarters of 2012, anti-smoking groups received at least $2.8 million from Pfizer:

American Academy of Pediatrics: $720,800
American Cancer Society: $252,750
American Heart Association: $136,000
American Lung Association: $190,250
Campaign for Tobacco-Free Kids: $100,000
American Medical Association: $857,500
American Legacy Foundation: $300,000
Action on Smoking and Health: $200,000

In addition, the 2012 National Conference on Tobacco or Health was sponsored by Pfizer.

And astonishingly, even the CDC is partnering with Pfizer.

I have already questioned these partnerships on the grounds that they undermine the scientific credibility of the anti-smoking movement, destroying the scientific objectivity of these groups' conclusions and recommendations regarding strategies to promote smoking cessation. Today, however, I question these partnerships on public health and ethical grounds.

The Rest of the Story

Since most, if not all, of the anti-smoking groups above have argued that electronic cigarettes should be banned because they contain detectable levels of a carcinogen - to which there is no safe level of exposure - these anti-smoking groups should jump into action with today's revelation that a substantial proportion of the nation's rice supply is contaminated with a carcinogen - arsenic - at levels that are considered to be unsafe for drinking water. Moreover, since arsenic is a carcinogen, these groups would argue that there is no safe level of exposure to arsenic to begin with. Certainly, they should view the finding that our nation's rice supply is contaminated with arsenic as a huge public health catastrophe.

The fact is that arsenic - a proven, human carcinogen - has been detected in rice at levels that exceed levels that are considered to be acceptable for drinking water. This is a particular problem in the southern U.S., especially in Arkansas, where rice growers have filed a lawsuit related to the high levels of arsenic in water used to grow rice. They argue that the arsenic contamination has resulted in levels in rice that may not be safe for children.

Where is the arsenic coming from and who is responsible?

The answer is ...

... Pfizer.

Up until last year, Pfizer marketed and sold a drug - Roxarsone - that when added to chicken feed helps spur chicken growth and produce a more attractive pink color which helps sell more chickens. The problem is that Roxarsone contains arsenic. And although it is organic arsenic, which is not hazardous, the drug is apparently converted to inorganic arsenic in the intestinal tract. Chicken litter therefore contains inorganic arsenic. Rice growers then use the poultry litter to fertilize their fields.

Thus, it is Pfizer which is apparently responsible for the high levels of arsenic that are being found in rice grown in the southern U.S. and which could potentially be threatening the health of children consuming that rice.

According to an article in Food Safety News:

"Arkansas rice growers say chicken industry practices promoted by industry giants like Pfizer, Tyson Foods Inc. and other big chicken producers are responsible for the high arsenic levels being detected in their crops. The growers have asked the Circuit Court for the Southern District of Arkansas for a jury trial to decide whether their claim that Pfizer, Tyson and half a dozen other poultry companies is justified. The growers blame those defendants for the high levels of arsenic found in rice grown in Arkansas waters. The federal lawsuit was filed just a few days after both Consumer Reports and the U.S. Food and Drug Administration (FDA) released data showing that white rice grown in Arkansas, Louisiana, Missouri and Texas may contain arsenic at levels that are too high for some, especially children. ... Pfizer Inc.’s animal feed additive business, known as Alpharma, is accused of selling arsenic-containing compounds such as a product called “3-Nitro,” used in chicken feed to spur the growth of chickens and prevent an intestinal disease called coccidiosis. The product contains organic arsenic that the rice growers’ say passes through chickens into their litter. ... ‘Most scientists and government agencies recognized “3-Nitro” to be highly toxic to humans and to be a recognized source of arsenic poisoning which can lead to various human health diseases and complications,' says the rice growers’ complaint." 

Although one might expect that Pfizer has reformed itself after the revelation that it may be responsible for poisoning much of the nation's rice supply, the company - in 2012 - continued to lobby against legislation that would ban arsenic and arsenic-containing drugs from chicken feed.

Sadly, through their partnerships with Pfizer, the American Academy of Pediatrics, American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, American Medical Association, American Legacy Foundation, Action on Smoking and Health, and CDC all share in the complicity that led to this public health disaster. These organizations should renounce their partnerships with Pfizer immediately.

Thursday, October 11, 2012

The Tide is Turning: Published Scientific Journal Articles are Beginning to Recommend Electronic Cigarettes as a Potential Smoking Cessation or Reduction Strategy

This week, two articles have been published which review the current state of treatment for smoking cessation. Both articles conclude that electronic cigarettes show promise and that these innovative products should be considered as strategies to promote smoking cessation or reduction.

In an article appearing in this month's issue of Nicotine & Tobacco Research, Brent Caldwell, Dr.Walt Sumner, and Julian Crane provide a systematic review of inhaled nicotine as a tool for smoking cessation. First, they point out the dismal effectiveness rates for traditional nicotine replacement therapy (NRT) products, noting that their long-term success rates are low. Second, they review current evidence on the use of various inhaled nicotine devices, including nicotine inhalers and electronic cigarettes. They conclude that these devices are unlikely to cause serious health problems. They also conclude that electronic cigarettes, in particular, show promise. Their ultimate conclusion is that: "Investment in development of therapeutic pulmonary nicotine devices is likely to result in a major advance in smoking cessation treatment and prevent considerable mortality and morbidity."

In an article appearing online ahead of print in the journal Internal and Emergency Medicine, Dr. Pasquale Caponnetto, Elaine Keller. Dr. Cosimo M. Bruno, and Dr. Riccardo Polosa provide a review of strategies to handle relapse in smoking cessation. They present an algorithm for responding to relapse and their approach includes the consideration of using harm reduction approaches such as electronic cigarettes. They conclude that: "Recent research with electronic cigarettes, battery-operated products designed for the purpose of nicotine delivery has found them to be safe and effective in helping smokers remain abstinent. ... Thus, advising smokers who cannot (or do not want to) quit to switch to either low-nitrosamine snuff or electronic cigarette could be an equally effective way to help smokers to become abstinent. This new emphasis on tobacco harm reduction as an exit strategy for smokers unable (or unwilling) to quit is a key paradigm shift in the management of relapse, which could save millions of lives world-wide."

The Rest of the Story

I think that the persistence and perseverance of harm reduction advocates, especially electronic cigarette advocacy groups and users, is finally starting to have an effect on public and scientific opinion. It would have been unheard of two years ago for a pair of articles to come out on the same day, both supporting the use of electronic cigarettes as a potential smoking cessation strategy.

That harm reduction is now on the mainstream agenda is a testament to the efforts of researchers and advocates who will not give up, including but not limited to the work of Bill Godshall, Scott Ballin, Dr. Carl Phillips, Dr. Brad Rodu, Paul Bergen, Dr. David Sweanor, Dr. Murray Laugesen, Dr. Jonathan Foulds, Dr. Gil Ross, and many others, as well as the efforts of advocacy groups such as CASAA (The Consumer Advocates for Smoke-Free Alternatives Association).

But most importantly, it is due to the testimony and dedication of the actual users of these products - notably, the many electronic cigarette users who have been willing to share their experiences with the media, the public, policy makers, and the harm reduction community. Their message is starting to be heard. Despite the ideological and political/financial barriers posed by many leading groups in the tobacco control movement, the overwhelming experience of tens of thousands of electronic cigarette users cannot be suppressed or ignored forever.

I finally see the tide beginning to turn.

Wednesday, October 10, 2012

FDA Requests Full Appeals Court Review of Its Rejection of Graphic Cigarette Warning Labels

According to a Bloomberg Businessweek article, the Justice Department has requested a full-court review of the ruling of a 3-judge panel from the D.C. Circuit Court of Appeals that invalidated the FDA's graphic warning label requirements for cigarettes. The panel had ruled, in a 2-1 decision, that the graphic warning label requirements violates the First Amendment because it forces the cigarette companies to allow the government to use their packages as mini anti-smoking billboards and because there is not sufficient evidence that this requirement will advance the government's interest in reducing smoking rates.

According to the article: "The U.S. government is asking a federal appeals court to rehear a challenge to a Food and Drug Administration requirement that tobacco companies to put large graphic health warnings on cigarette packages to show that smoking can disfigure and even kill people. The Justice Department filed a petition Tuesday asking for the full court to rehear the case after a three-judge panel of the U.S. Court of Appeals in Washington affirmed in August a lower court ruling blocking the mandate, saying it ran afoul of the First Amendment's free speech protections. However, the court rarely grants such appeals." ...

"In a 2-1 decision, the appeals court panel wrote that the case raises "novel questions about the scope of the government's authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest — in this case, by making 'every single pack of cigarettes in the country (a) mini billboard' for the government's anti-smoking message."
The court also wrote that the FDA "has not provided a shred of evidence" showing that the warnings will "directly advance" its interest in reducing the number of Americans who smoke." ...

"But in its appeal seeking a full court rehearing, the government argued that the text of the new warnings are "indisputably accurate" and the format, including the use of graphics, is tailored to the demand of a "market in which the vast majority of users become addicted to a lethal product before age 18." It also argued that the First Amendment does not require the government to show how one part of a multi-faceted anti-smoking public health campaign directly reduces smoking rates."

The Rest of the Story

There are a number of factors that influence the decision of whether to grant en banc (full Court) review of an appeals court panel's decision. Giles et al. provide a fascinating, systematic, analytic study of these factors, considering both ideological and legal concerns. Although granting en banc review is not common, it is often granted in cases of "extraordinary" significance or in cases where there are disagreements between appeals courts on similar issues. It is possible that the graphic warning label issue meets these criteria.

In any case, the fact that the Department of Justice is requesting an en banc review suggests to me that it will indeed appeal the case to the Supreme Court (if the full Appeals Court fails to overturn its panel's decision). And I think the Supreme Court will most certainly take the case.

Thus, I believe the ultimate disposition of the case is going to occur at the Supreme court level.

Tuesday, October 09, 2012

How Can the American Academy of Pediatrics and Other Public Health Groups Continue to Partner with Coca-Cola and Pepsi?

Today, the Rest of the Story is questioning how the American Academy of Pediatrics, American Dietetic Association, American Academy of Family Physicians, and American Diabetes Association can continue their corporate partnerships with the Coca-Cola Company and/or PepsiCo after it was revealed that these companies are spending millions of dollars to defeat a California ballot initiative -Proposition 37 - that would simply require labeling of genetically modified foods so that consumers could make an informed choice about what they want to eat.

Apparently, the Coca-Cola Company has spent $1.2 million to defeat the measure and PepsiCo has spent $1.7 million. In opposing this simple "right-to-know" measure, these partners of the AAP, ADA, and AAFP are joining their other friends in the Big Food and Big Chemicals industry, including Monsant, Dupont, Dow Chemical, BASF, Nestle, and ConAgra.

Thus, Coke and Pepsi have joined other corporations that are in Corporate Accountability International's corporate Hall of Shame to oppose this basic public health information initiative.

According to an article at Current TV, pesticide and junk food companies are spending $35 million to flood the airwaves with lies and deception about the ballot initiative. And "the No on 37 campaign's already tattered credibility was dealt yet another big blow with news that its "top scientist" is nothing more than a corporate shill willing to misrepresent himself and the University for which he works."

According to the article: "Henry Miller - a spokesperson the No on 37 campaign has been all too eager to promote as an arbiter of good science and someone we can trust with our families health. Miller has been featured in No on 37 television ads, written outrageously deceptive opinion editorials, and has presented himself as an "unbiased" scientific expert. And now he's been caught misrepresenting Stanford University- forcing the No on 37 Campaign to pull and reshoot a statewide television ad identifying Miller as "Dr. Henry Miller, MD, Stanford University," without disclosing his affiliation with the Hoover Institute, a right-wing think tank at the University. In other words, he works ON the Stanford campus as a corporate propagandist, but ISN'T a Professor at Stanford University. The ad was pulled after the Yes on 37 campaign attorney sent a letter to Stanford pointing out that the university's affiliation was being used in a political advertising campaign, in violation of university policy. Stanford also demanded that the campaign remove the campus from the ad's background."

Thus, the Coca-Cola Company and PepsiCo are a part of this shameful, deceptive campaign designed to undermine the protection of the public's health via the least intrusive available measure: simple information.

The Rest of the Story

The hypocrisy of the two major soft drink companies in opposing this initiative is difficult to believe. It was best summarized by Yes on 37 supporter Alex Bogusky in a recent Advertising Age article, in which he points out: 

"It's ironic that these same companies are suggesting that consumers have a right to choose as they fight Bloomberg in New York, but then turn around and fund the effort to keep consumers in the dark on GMOs. I guess they only support your right to choose when they're certain that you'll make the choice that they want you to make."

Although the No on 37 corporations have outspent the public health advocates supporting this measure by approximately $33 million to just $4 million, California voters will certainly approve this simple right-to-know law that supports consumer choice and autonomy. Sadly, not only will the Big Food and chemical companies be going down, but the American Academy of Pediatrics, American Dietetic Association, American Academy of Family Physicians, and American Diabetes Association will be going down with them.

Monday, October 08, 2012

New Gallup Poll Results Suggest that Exaggeration of the Effects of Secondhand and Thirdhand Smoke is Backfiring

A new Gallup poll shows that the public's appreciation of the hazards of secondhand smoke, which had been increasing prior to 2002, has remained steady since then without any further progress. This stifling of the progress in educating the public about the hazards of secondhand smoke coincides with the anti-smoking movement's decision to start exaggerating these effects and to invent and exaggerate the new hazard of thirdhand smoke.

The proportion of the population that believes secondhand smoke is very harmful increased dramatically from 36% in 1994 to 56% in 2002. However, the Gallup data show that this proportion has plateaued, remaining steady throughout the past decade and remaining at 56% in the latest poll taken this year.

The poll also shows that the proportion of both smokers and nonsmokers who believe secondhand smoke is very harmful has remained steady since 2002.

The analysis of the results by Gallup concludes: "Americans are significantly more likely to say smoking is harmful than they are to say the same for exposure to secondhand smoke. This gap has remained steady over the past decade, despite a growing number of studies demonstrating the harmful effects of secondhand smoke."

"The CDC released several graphic anti-smoking public service announcements over a 12-week period starting March 2012 that showed the harmful effects of smoking to encourage current smokers to quit. Overall, U.S. smokers were no more likely to say in July 2012 that smoking is very harmful, although the prevalence of smokers tied an all-time low, the percentage of heavy smokers dropped to an all-time low, and 78% of smokers say they would like to quit."

The Rest of the Story

What changed around 2002, the turning point that ended a decade of progress in educating the public about the serious hazards of secondhand smoke?

What changed was that the anti-smoking movement began to exaggerate the health effects of secondhand smoke, telling the public that just 30 minutes of secondhand smoke could cause heart attacks in otherwise healthy people, asserting that secondhand smoke exposure is as harmful as smoking, and starting to scare the public about undocumented hazards of thirdhand smoke.

Clearly, this exaggeration strategy has backfired, as progress in educating the public about the serious hazards of secondhand smoke has come to a complete halt, both among smokers and nonsmokers.

Why? Because by exaggerating and distorting the science, the anti-smoking movement has begun to lose its credibility and the public is no longer believing everything it hears from anti-smoking groups.

Smokers, in particular, seem to be discounting messages from anti-smoking groups. Only 28% of smokers in 2012 believe that secondhand smoke is very harmful. Perhaps even worse, there has been no progress in educating smokers about the harmful effects of active smoking. Only 60% of smokers believe that smoking is very harmful, a percentage that is exactly the same as what it was in 2002.

By lying to the public and trying to convince them that secondhand smoke is as hazardous as smoking, anti-smoking groups have accomplished the unfortunate result of having downplayed the very real hazards of active smoking, resulting in a situation where two out of every five smokers today do not believe that smoking is very hazardous.

The rest of the story is that with its gross exaggeration and distortion of the science on secondhand and thirdhand smoke, the anti-smoking movement has succeeded in halting progress in the education of the public about the severe hazards associated with both secondhand smoke and active smoking. This is a result of the damaged credibility of the anti-smoking movement due to its willingness to sacrifice its scientific integrity in favor of exaggerating and distorting the science in order to try to produce more dramatic sound bites.