My perspective article, published yesterday in the New England Journal of Medicine, criticizes the FDA Tobacco Products Scientific Advisory Committee (TPSAC) for failing to recommend a ban on menthol cigarettes, arguing that this was a lost opportunity for public health.
I write: "Although some public health groups hailed as a public health victory the release of a report on menthol cigarettes by the Tobacco Products Scientific Advisory Committee (TPSAC) of the Food and Drug Administration (FDA), close examination of the report and its recommendations reveals that it actually represents a huge victory for Lorillard, the manufacturer of the leading brand of menthol cigarettes (Newport) — and a disappointing setback for the health of black Americans."
The article then points out that "the TPSAC did not recommend a ban on menthol cigarettes. Instead, the report simply stated, “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.” Thus, the committee’s basic “recommendation” is not a recommendation at all, but a conclusion that doesn’t suggest any particular action to the FDA."
I argue that "it is specifically because Congress knew that a menthol ban would substantially benefit the public’s health (by decreasing tobacco sales) that politicians chose to exempt menthol from the Tobacco Act in the first place. It is because a menthol ban would actually reduce tobacco sales that an advocacy group called the Campaign for Tobacco-Free Kids and other health groups supporting the tobacco-regulation legislation ensured that such a ban was not included in it — since it would have risked the loss of Philip Morris’s support for the law and the crumbling of the deal that had been forged with the country’s largest tobacco company. The mandate for the TPSAC to study the menthol issue was actually a compromise forged to appease the Black Congressional Caucus, which vigorously denounced the exclusion of menthol from the bill’s flavoring ban. The Campaign for Tobacco-Free Kids, for its part, opposed an amendment that would have eliminated the menthol exemption, defending that opposition by warning that if menthol were banned, a black market in contraband cigarettes was likely to be created — an argument that had been made vigorously by Lorillard."
Two members of the TPSAC - Dr. Samet and Dr. Benowitz - wrote a corresponding perspective article about the TPSAC menthol report. In it, they argue that: "The TPSAC, a scientific advisory committee, was not charged with addressing regulatory options and did not have the time or expertise to analyze regulatory scenarios, including any involving inadvertently opening a door for the introduction of contraband menthol cigarettes into the U.S. market."
The Rest of the Story
Drs. Samet and Benowitz argue that the TPSAC is a scientific body and is therefore not charged with addressing regulatory options. If every FDA scientific panel made the same argument, there would be no drugs on the market. After all, every FDA scientific panel is charged not simply with examining the science, but with making a recommendation to the agency with respect to policy: namely, whether to approve or disapprove a pharmaceutical company's application for a drug to be placed on the market.
Can you imagine if an FDA scientific advisory panel came back to the agency with a recommendation stating: “This drug treats hypertension and would therefore improve the public’s health, but there are some serious potential side effects that need to be studied.” That gives the agency no guidance in terms of what action to take. The entire point of the advisory panel is to recommend a policy action to the FDA.
Moreover, the argument that TPSAC was not charged with addressing regulatory options flies in the face of its legislative mandate. The Family Smoking Prevention and Tobacco Control Act mandated that the TPSAC issue not only a scientific report, but also a "recommendation" to the FDA regarding the regulation of menthol cigarettes.
Moreover, the Act mandated that TPSAC examine not only the public health impact of menthol cigarettes, but also the potential black market and contraband concerns. The Committee was to weigh these factors in making its recommendation to the Agency.
Here is the text of the Congressionally-mandated charge to TPSAC, in section 907(e) of the Tobacco Control Act:
"(e) MENTHOL CIGARETTES.—
‘‘(1) REFERRAL; CONSIDERATIONS.—Immediately upon the establishment of the Tobacco Products Scientific Advisory Committee under section 917(a), the Secretary shall refer to the
Committee for report and recommendation, under section 917(c)(4), the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsections (a)(3)(B)(i) and (b).
‘‘(2) REPORT AND RECOMMENDATION.—Not later than 1 year after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1).
It should be immediately apparent to readers that TPSAC failed to complete its mandate because it did not issue any "recommendations" to the Agency regarding the regulation of menthol cigarettes. Clearly, the legislation asks the TPSAC to make recommendations to the Agency. If it had required only a scientific report, it would have stated that the Committee issue "a report," not a "report and recommendations." The TPSAC did the former, but not the latter.
What may not be so apparent is that TPSAC was charged not only with examining the public health impact of menthol, but also the black market/contraband concerns. According to the law, TPSAC "shall address" the considerations in subsections (a)(3)(B)(i) and (b). What exactly are these considerations?
The consideration in subsection (a)(3)(B)(i) is simple. It's the public health impact of menthol cigarettes. Specifically: "(i) CONSIDERATIONS.—In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning— (I) the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard; (II) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (III) the increased or decreased likelihood that those who do not use tobacco products will start using such products."
In other words, TPSAC was mandated to consider the effects of a menthol ban on disease risk, smoking initiation and smoking cessation. It did carry out that mandate.
However, TPSAC was also charged with addressing the considerations in section 907(b):
"The Secretary shall consider all other information submitted in connection with a proposed standard, including information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements of this chapter and the significance of such demand."
Thus, the law specifically mandates that TPSAC must consider the potential concerns regarding a black market or contraband in developing its report and recommendations. TPSAC did not carry out this mandate. Instead, it simply punted the issue back to FDA, urging the FDA to conduct the analysis that TPSAC was supposed to conduct.
More importantly, the clear intent of the legislative mandate was that TPSAC weigh the public health benefits of a menthol ban against the black market/contraband concerns and come up with an overall recommendation taking both into account. This is what would have been helpful to the FDA and this is what the law called for.
The rest of the story, then, is that not only did the TPSAC do the public a disservice by wasting all this time studying the issue but failing to make a recommendation. In addition, the TPSAC failed to carry out or fulfill its Congressional mandate.
This is a shame not only because the Committee wasted time and resources. It is a shame because the Committee wasted what could have been an opportunity to promote the one action that the FDA could have taken that would actually have improved the public's health. The Committee, however, was too weak-willed for that. It would have required actually standing up to Big Tobacco.
As I conclude in the article: "At the end of the day, it is difficult to understand the rationale for a policy that bans every other type of cigarette flavoring — including chocolate, strawberry, banana, pineapple, cherry, and kiwi — yet exempts the one flavoring that is actually used extensively by tobacco companies to recruit and maintain smokers, a finding that has been documented extensively by the TPSAC itself. Ironically, it is because removing menthol would actually improve the public’s health by reducing the consumption of cigarettes that we are not going to see such an action from the federal government. There is no political risk in banning chocolate and strawberry cigarettes, since no companies are currently selling such products and they play no role in smoking initiation. Menthol, however, is a major contributor to smoking initiation and continued addiction, and for this reason, it will continue to enjoy the protection of a federal government that seems afraid to alienate any corporation, whether it’s part of Big Pharma, Big Insurance, or Big Tobacco."
Thursday, May 05, 2011
Tuesday, May 03, 2011
A Sad Day: Tobacco Companies Telling the Truth, But Anti-Smoking Groups are Not; New Research Invalidates Entire Premise of FDA Tobacco Act
The Campaign for Tobacco-Free Kids, supported by other national anti-smoking groups, has argued that one of the major public health benefits of the Tobacco Act, which they argue will save "countless lives," is that the FDA has the authority to regulate the levels of specific tobacco constituents.
The Campaign, for example, boasted to the public that "the reduction or elimination of harmful ingredients, additives and constituents" will protect the public's health and save "countless lives." The Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, and American Cancer Society told the American people that one of the key benefits of the Tobacco Act is that "FDA will have authority to require manufacturers to reduce or eliminate harmful ingredients and/or smoke constituents where technologically feasible."
Through these statements, the anti-smoking groups are implying that reducing or eliminating specific harmful constituents in tobacco smoke will result in a safer cigarette that will save lives and improve the public's health.
There is, however, no scientific evidence that reducing the level of or removing specific constituents in tobacco smoke would result in a safer cigarette.
For example, an article published in the March 2007 issue of Cancer Epidemiology, Biomarkers & Prevention concludes that even if all currently known and measured carcinogens in tobacco smoke were completely removed, there would be little reason to believe that there would be any observable reduction in smoking-related cancers (see: Pankow JF, Watanabe KH, Toccalino PL, Luo W, Austin DF. Calculated cancer risks for conventional and 'potentially reduced exposure product' cigarettes. Cancer Epidemiology, Biomarkers & Prevention 2007; 16:584-592).
The researchers found that knowledge of the yields of all currently known lung carcinogens in cigarettes was able to account for less than 4% of the observed lung cancer risk of cigarette smoking. This inability to account for observed cancer risk means, they conclude, that even if all currently known and measured carcinogens were completely removed from cigarette smoke, there would be no reason to believe that actual human cancer risk would be decreased.
The authors conclude: "The current inability to account for the observed health risks of smoking based on existing data indicates that current expressed/implied marketing promises of reduced harm from PREPs are unverified: there is little reason to be confident that total removal of the currently measured human lung carcinogens would reduce the incidence of lung cancer among smokers by any noticeable amount."
"Expressed another way, even if a PREP design were to succeed in removing all currently measured known human lung carcinogens from cigarette smoke (and even perhaps all other currently measured carcinogens), there would be little reason to be confident that such removal would by itself lead to any observable reduction in smoking related lung cancer."
The Rest of the Story
In contrast to the anti-smoking groups, the tobacco industry is telling the truth about the lack of evidence that reducing or eliminating specific tobacco smoke constituents would produce a safer cigarette. Last week, Chris Proctor, the chief scientist at British American Tobacco stated: "Even if you can reduce the levels of a significant number of toxicants in tobacco smoke, there is no guarantee that this will result in reduced exposure in people or result in a reduction in health risks."
Sadly, this is an important point that the Campaign for Tobacco-Free Kids and its supporting national anti-smoking groups, like the American Cancer Society, are not telling the public.
Dr. Proctor's statement comes in the context of a tobacco industry study showing that tobacco can be treated in a way that largely removes certain harmful proteins and polyphenols, resulting in cigarettes that deliver much lower levels of hydrogen cyanide, aromatic amines, and tobacco-specific nitrosamines.
Unlike the anti-smoking groups, however, these tobacco industry researchers were honest in disclosing to the public that: "It is not possible to judge from the smoke chemistry whether cigarettes that include tobacco treated in this manner would reasonably be expected to reduce the risk of one or more specific diseases or other adverse health effects associated with smoking. The 43 toxicants that were measured for this study represent a small fraction of around 5,000 chemical constituents that have been identified in mainstream smoke."
It is truly a sad day for tobacco control when the tobacco companies are being honest about the relationship between measured toxicants and disease risk, while the anti-smoking groups are wildly deceiving the public about the very same scientific issue.
The Campaign, for example, boasted to the public that "the reduction or elimination of harmful ingredients, additives and constituents" will protect the public's health and save "countless lives." The Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, and American Cancer Society told the American people that one of the key benefits of the Tobacco Act is that "FDA will have authority to require manufacturers to reduce or eliminate harmful ingredients and/or smoke constituents where technologically feasible."
Through these statements, the anti-smoking groups are implying that reducing or eliminating specific harmful constituents in tobacco smoke will result in a safer cigarette that will save lives and improve the public's health.
There is, however, no scientific evidence that reducing the level of or removing specific constituents in tobacco smoke would result in a safer cigarette.
For example, an article published in the March 2007 issue of Cancer Epidemiology, Biomarkers & Prevention concludes that even if all currently known and measured carcinogens in tobacco smoke were completely removed, there would be little reason to believe that there would be any observable reduction in smoking-related cancers (see: Pankow JF, Watanabe KH, Toccalino PL, Luo W, Austin DF. Calculated cancer risks for conventional and 'potentially reduced exposure product' cigarettes. Cancer Epidemiology, Biomarkers & Prevention 2007; 16:584-592).
The researchers found that knowledge of the yields of all currently known lung carcinogens in cigarettes was able to account for less than 4% of the observed lung cancer risk of cigarette smoking. This inability to account for observed cancer risk means, they conclude, that even if all currently known and measured carcinogens were completely removed from cigarette smoke, there would be no reason to believe that actual human cancer risk would be decreased.
The authors conclude: "The current inability to account for the observed health risks of smoking based on existing data indicates that current expressed/implied marketing promises of reduced harm from PREPs are unverified: there is little reason to be confident that total removal of the currently measured human lung carcinogens would reduce the incidence of lung cancer among smokers by any noticeable amount."
"Expressed another way, even if a PREP design were to succeed in removing all currently measured known human lung carcinogens from cigarette smoke (and even perhaps all other currently measured carcinogens), there would be little reason to be confident that such removal would by itself lead to any observable reduction in smoking related lung cancer."
The Rest of the Story
In contrast to the anti-smoking groups, the tobacco industry is telling the truth about the lack of evidence that reducing or eliminating specific tobacco smoke constituents would produce a safer cigarette. Last week, Chris Proctor, the chief scientist at British American Tobacco stated: "Even if you can reduce the levels of a significant number of toxicants in tobacco smoke, there is no guarantee that this will result in reduced exposure in people or result in a reduction in health risks."
Sadly, this is an important point that the Campaign for Tobacco-Free Kids and its supporting national anti-smoking groups, like the American Cancer Society, are not telling the public.
Dr. Proctor's statement comes in the context of a tobacco industry study showing that tobacco can be treated in a way that largely removes certain harmful proteins and polyphenols, resulting in cigarettes that deliver much lower levels of hydrogen cyanide, aromatic amines, and tobacco-specific nitrosamines.
Unlike the anti-smoking groups, however, these tobacco industry researchers were honest in disclosing to the public that: "It is not possible to judge from the smoke chemistry whether cigarettes that include tobacco treated in this manner would reasonably be expected to reduce the risk of one or more specific diseases or other adverse health effects associated with smoking. The 43 toxicants that were measured for this study represent a small fraction of around 5,000 chemical constituents that have been identified in mainstream smoke."
It is truly a sad day for tobacco control when the tobacco companies are being honest about the relationship between measured toxicants and disease risk, while the anti-smoking groups are wildly deceiving the public about the very same scientific issue.
Monday, May 02, 2011
Study Finds Secondhand Smoke Associated With Higher Blood Pressure in Boys, But Lower Blood Pressure in Girls; Concludes Effect is Real Only for Boys
According to newspapers throughout the world, secondhand smoke has been found to cause higher blood pressure in boys, based on a new study presented yesterday at the annual meeting of the Pediatric Academic Societies in Denver.
For example, the Guardian headline reads: "Passive smoking raises blood pressure in boys, study reveals."
The headline in the Mirror read: "Second-hand smoke can raise boys' blood pressure and cause heart disease."The press release put out by the researchers themselves is titled: "Living with a smoker may raise blood pressure in boys."
The study examined the cross-sectional relationship between exposure to secondhand smoke (assessed by serum cotinine levels) and blood pressure in children ages 8-17 from the National Health and Nutrition Examination Survey (NHANES) for the years 1999 through 2006. The research controlled for the following potential confounding factors: age, gender, body mass index, sodium intake, and physical activity.
One of the major findings was that systolic blood pressure among boys exposed to secondhand smoke was 1.6 mm Hg higher than among boys not exposed to secondhand smoke in the home.
The lead study author stated: "While the increases in blood pressure observed among boys in our study may not be clinically meaningful for an individual child, they have large implications for populations."
The study concluded that: "The potential long-term cardiovascular risk of higher BP among ETS-exposed boys provides further incentive to expand policies that create smoke-free environments for children and adolescents."
What the authors are therefore concluding is that the increase in systolic blood pressure among tobacco smoke-exposed boys, even though it was small (1.6 mm Hg) is enough to increase long-term rates of hypertension in the population, leading to increased rates of cardiovascular disease.
The Rest of the Story
What the press release headline doesn't tell you is that the very same study found that among girls, secondhand smoke exposure was associated with a significant decrease in systolic blood pressure. Girls living with a smoker had systolic blood pressure that was 1.8 mm Hg lower than girls who did not live with a smoker.
Thus, it must also be the case that: "While the decreases in blood pressure observed among girls in our study may not be clinically meaningful for an individual child, they have large implications for populations." The potential long-term cardiovascular risk of higher BP among non-ETS-exposed girls provides incentive to limit policies that create smoke-free environments for children and adolescents."
You see, you can't have it both ways. If secondhand smoke exposure increases systolic blood pressure in boys and you conclude that this small difference in blood pressure is going to affect long term cardiovascular disease risk, then you must also acknowledge that the higher systolic blood pressure among non-exposed girls is also going to affect long term cardiovascular disease risk.
In other words, if the children in this study could be followed for many years, according to the scientific reasoning of the study authors, the cardiovascular disease risks of boys who lived with a smoker would be increased, but the cardiovascular disease risks of girls who lived with a smoker would be decreased, if we accept the findings of this study as accurate and valid.
Since the authors argue that this study provides evidence to support smoking bans, they clearly are concluding that the observed increase in blood pressure among boys living with smokers is a real effect, but that the observed decrease in blood pressure among girls living with a smoker is an invalid finding.
In other words, the authors are concluding that their data and findings with regards to the males in their study are valid, but they are completely dismissing the findings with regards to the females in their study.
In addition, the study conclusion disregards the actual finding of the study regarding the observed effect among females. The study concludes: "ETS exposure was associated with significantly higher SBP [systolic blood pressure] in boys, but not girls."
But that is a false statement of the findings. The results did not merely show that ETS exposure was not associated with higher SBP in girls. Instead, the results showed that ETS exposure was significantly associated with decreased SBP in girls.
The study authors apparently try to explain this away by arguing that somehow, girls are not subject to the same cardiovascular effects of secondhand smoke exposure that boys are. This is hardly a plausible explanation. Instead, it seems like a post-hoc excuse that was concocted in order to allow the investigators to draw the conclusion that they wanted to draw.
Moreover, this would only explain the failure to find an association between secondhand smoke exposure and blood pressure in girls. It would not explain the finding of decreased blood pressure among secondhand smoke-exposed girls. Thus, this explanation is invalid on its face.
I have to say that this appears to be one of the most blatant examples of investigator bias in a research study that I've seen. You set out to examine the relationship between secondhand smoke exposure and blood pressure. You find that exposed boys have higher blood pressure and exposed girls have lower blood pressure. You conclude that your findings for males are accurate and valid and that your findings for females are inaccurate and invalid.
If this doesn't appear to be manipulation of data interpretation in order to reach pre-determined conclusions, than I don't know what does.
The rest of the story is that these study conclusions are strikingly biased. The authors appear to have reached a pre-determined conclusion and they appear to have awkwardly and unconvincingly manipulated the interpretation of the study findings in order to support that pre-determined conclusion.
And to add insult to injury, the conclusions of the study are disseminated widely to the media via the "research by press release" approach that I despise. This work hasn't even been peer reviewed yet, but its conclusions are now being read throughout the world. Most of the readers of these publications will never know the rest of the story.
Scientific research and data interpretation needs to be an objective, systematic, and consistent process. You can't simply accept half of your findings and dismiss the other half, especially without a definitive reason. While this might provide some short-term support for smoking bans, in the long run, this harms the scientific credibility and integrity of the tobacco control movement.
For example, the Guardian headline reads: "Passive smoking raises blood pressure in boys, study reveals."
The headline in the Mirror read: "Second-hand smoke can raise boys' blood pressure and cause heart disease."The press release put out by the researchers themselves is titled: "Living with a smoker may raise blood pressure in boys."
The study examined the cross-sectional relationship between exposure to secondhand smoke (assessed by serum cotinine levels) and blood pressure in children ages 8-17 from the National Health and Nutrition Examination Survey (NHANES) for the years 1999 through 2006. The research controlled for the following potential confounding factors: age, gender, body mass index, sodium intake, and physical activity.
One of the major findings was that systolic blood pressure among boys exposed to secondhand smoke was 1.6 mm Hg higher than among boys not exposed to secondhand smoke in the home.
The lead study author stated: "While the increases in blood pressure observed among boys in our study may not be clinically meaningful for an individual child, they have large implications for populations."
The study concluded that: "The potential long-term cardiovascular risk of higher BP among ETS-exposed boys provides further incentive to expand policies that create smoke-free environments for children and adolescents."
What the authors are therefore concluding is that the increase in systolic blood pressure among tobacco smoke-exposed boys, even though it was small (1.6 mm Hg) is enough to increase long-term rates of hypertension in the population, leading to increased rates of cardiovascular disease.
The Rest of the Story
What the press release headline doesn't tell you is that the very same study found that among girls, secondhand smoke exposure was associated with a significant decrease in systolic blood pressure. Girls living with a smoker had systolic blood pressure that was 1.8 mm Hg lower than girls who did not live with a smoker.
Thus, it must also be the case that: "While the decreases in blood pressure observed among girls in our study may not be clinically meaningful for an individual child, they have large implications for populations." The potential long-term cardiovascular risk of higher BP among non-ETS-exposed girls provides incentive to limit policies that create smoke-free environments for children and adolescents."
You see, you can't have it both ways. If secondhand smoke exposure increases systolic blood pressure in boys and you conclude that this small difference in blood pressure is going to affect long term cardiovascular disease risk, then you must also acknowledge that the higher systolic blood pressure among non-exposed girls is also going to affect long term cardiovascular disease risk.
In other words, if the children in this study could be followed for many years, according to the scientific reasoning of the study authors, the cardiovascular disease risks of boys who lived with a smoker would be increased, but the cardiovascular disease risks of girls who lived with a smoker would be decreased, if we accept the findings of this study as accurate and valid.
Since the authors argue that this study provides evidence to support smoking bans, they clearly are concluding that the observed increase in blood pressure among boys living with smokers is a real effect, but that the observed decrease in blood pressure among girls living with a smoker is an invalid finding.
In other words, the authors are concluding that their data and findings with regards to the males in their study are valid, but they are completely dismissing the findings with regards to the females in their study.
In addition, the study conclusion disregards the actual finding of the study regarding the observed effect among females. The study concludes: "ETS exposure was associated with significantly higher SBP [systolic blood pressure] in boys, but not girls."
But that is a false statement of the findings. The results did not merely show that ETS exposure was not associated with higher SBP in girls. Instead, the results showed that ETS exposure was significantly associated with decreased SBP in girls.
The study authors apparently try to explain this away by arguing that somehow, girls are not subject to the same cardiovascular effects of secondhand smoke exposure that boys are. This is hardly a plausible explanation. Instead, it seems like a post-hoc excuse that was concocted in order to allow the investigators to draw the conclusion that they wanted to draw.
Moreover, this would only explain the failure to find an association between secondhand smoke exposure and blood pressure in girls. It would not explain the finding of decreased blood pressure among secondhand smoke-exposed girls. Thus, this explanation is invalid on its face.
I have to say that this appears to be one of the most blatant examples of investigator bias in a research study that I've seen. You set out to examine the relationship between secondhand smoke exposure and blood pressure. You find that exposed boys have higher blood pressure and exposed girls have lower blood pressure. You conclude that your findings for males are accurate and valid and that your findings for females are inaccurate and invalid.
If this doesn't appear to be manipulation of data interpretation in order to reach pre-determined conclusions, than I don't know what does.
The rest of the story is that these study conclusions are strikingly biased. The authors appear to have reached a pre-determined conclusion and they appear to have awkwardly and unconvincingly manipulated the interpretation of the study findings in order to support that pre-determined conclusion.
And to add insult to injury, the conclusions of the study are disseminated widely to the media via the "research by press release" approach that I despise. This work hasn't even been peer reviewed yet, but its conclusions are now being read throughout the world. Most of the readers of these publications will never know the rest of the story.
Scientific research and data interpretation needs to be an objective, systematic, and consistent process. You can't simply accept half of your findings and dismiss the other half, especially without a definitive reason. While this might provide some short-term support for smoking bans, in the long run, this harms the scientific credibility and integrity of the tobacco control movement.
Thursday, April 28, 2011
Article on Short-Term Effects of Chantix Fails to Even Mention Severe Side Effects; Could Conflict of Interest Be the Explanation?
Despite the fact that people are dying from taking Chantix due to its nearly immediate mental health effects, a new article on the short-term effectiveness of Chantix fails to even make mention of the existence of these severe side effects.
The article (Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji A-R. Use of Varenicline for 4 Weeks Before Quitting Smoking: Decrease in Ad Lib Smoking and Increase in Smoking Cessation Rates. Archives of Internal Medicine 2011; 171(8):770-777) assesses the effectiveness and side effects of pre-cessation use of Chantix combined with post-cessation use of the drug, and follows patients for one month following their quit attempt.
It reports on relatively minor side effects such as nausea. However, it fails to report, mention, or acknowledge the severe side effects that have been observed with Chantix, including major psychological symptoms, depression, wide mood swings, violent and suicidal ideation, and attempted and completed suicide. The study even assessed depressive symptoms in patients, but does not report these results.
The glaring lack of even a mention of the severe side effects of Chantix is a surprising act of omission.
The Rest of the Story
However, that surprise disappears when one gets to the bottom of the article, in the fine print, where it discloses that the study was funded by Pfizer (the maker of Chantix) and that several of the authors have financial conflicts of interests with pharmaceutical companies that make smoking cessation drugs.
Regarding the research funding, the article discloses: "This study was supported by an investigator-initiated grant from Pfizer (Dr Hajek), who also supplied the study medication."
Regarding the conflicts of interest, the article discloses: "Drs Hajek and McRobbie have received research funding from and provided consultancy to manufacturers of smoking cessation medications. Mr Stapleton was formally an adviser to manufacturers of smoking cessation medications, for which he received remuneration and hospitality."
It therefore comes as no surprise, actually, to find that the article makes no mention of the fact that hundreds of patients have experienced severe and often violent side effects, that nearly 100 have committed suicide, and that several bodies which have examined these case histories appear to have concluded that these adverse effects were indeed caused by the medication.
While I find it quite sad that so many people have needlessly lost their lives due to Chantix, I find it disturbing and unacceptable that bias caused by financial conflicts of interest has most likely contributed to these deaths.
The article (Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji A-R. Use of Varenicline for 4 Weeks Before Quitting Smoking: Decrease in Ad Lib Smoking and Increase in Smoking Cessation Rates. Archives of Internal Medicine 2011; 171(8):770-777) assesses the effectiveness and side effects of pre-cessation use of Chantix combined with post-cessation use of the drug, and follows patients for one month following their quit attempt.
It reports on relatively minor side effects such as nausea. However, it fails to report, mention, or acknowledge the severe side effects that have been observed with Chantix, including major psychological symptoms, depression, wide mood swings, violent and suicidal ideation, and attempted and completed suicide. The study even assessed depressive symptoms in patients, but does not report these results.
The glaring lack of even a mention of the severe side effects of Chantix is a surprising act of omission.
The Rest of the Story
However, that surprise disappears when one gets to the bottom of the article, in the fine print, where it discloses that the study was funded by Pfizer (the maker of Chantix) and that several of the authors have financial conflicts of interests with pharmaceutical companies that make smoking cessation drugs.
Regarding the research funding, the article discloses: "This study was supported by an investigator-initiated grant from Pfizer (Dr Hajek), who also supplied the study medication."
Regarding the conflicts of interest, the article discloses: "Drs Hajek and McRobbie have received research funding from and provided consultancy to manufacturers of smoking cessation medications. Mr Stapleton was formally an adviser to manufacturers of smoking cessation medications, for which he received remuneration and hospitality."
It therefore comes as no surprise, actually, to find that the article makes no mention of the fact that hundreds of patients have experienced severe and often violent side effects, that nearly 100 have committed suicide, and that several bodies which have examined these case histories appear to have concluded that these adverse effects were indeed caused by the medication.
While I find it quite sad that so many people have needlessly lost their lives due to Chantix, I find it disturbing and unacceptable that bias caused by financial conflicts of interest has most likely contributed to these deaths.
Wednesday, April 27, 2011
TPSAC Menthol Report Already Being Used to Block Menthol Ban; Commitee Doesn't Know What It's Saying When Arguing that Its Recommendation Was Clear
The FDA's Tobacco Products Scientific Advisory Committee (TPSAC) report and "recommendations" on menthol cigarettes is already being used to block a menthol ban, demonstrating that the TPSAC didn't know what it was talking about when it argued that its report clearly recommended that menthol cigarettes be banned.
Last week, Senator Richard Blumenthal wrote to the FDA seeking a ban on menthol cigarettes. In response, however, the Center for Regulatory Effectiveness (CRE) - citing TPSAC's own report - noted that the FDA cannot ban menthol cigarettes until a study is carried out on the issue of contraband cigarettes that could arise if menthol cigarettes are banned.
According to CRE's press release: "Senator Blumenthal states that his recommendation to ban menthol cigarettes is based on the report of the FDA Tobacco Product Scientific Advisory Committee. Unfortunately he must have not read the report in its entirety. The TPSAC made it clear that no action can be taken on a ban until the issue of contraband has been addressed."
The Rest of the Story
The Center for Regulatory Effectiveness is absolutely correct. The TPSAC's report, rather than recommend a ban on menthol, actually cautioned against such a ban, requesting that the FDA conduct a study of the contraband issue before embracing any particular policy regarding menthol.
Nevertheless, the chair of the TPSAC panel told the media that the Committee did in fact make a clear recommendation. This flies in the face of the clear language of the TPSAC's report.
The rest of the story is that rather than offer a recommendation, TPSAC punted the issue back to the FDA and shirked its responsibility. The Committee was statutorily charged with making a recommendation to the FDA about whether to ban menthol cigarettes, taking into account the issue of potential contraband. The Committee failed to carry out this charge.
At the end of the day, all the TPSAC menthol report actually does is put an even larger hurdle in the path of a potential menthol cigarette ban. It delays any such policy by years, requiring the FDA [unless the Agency ignores the report] to conduct a contraband study before even proposing a policy. Most importantly, it gives the Agency an out whereby it can respond to politicians like Blumenthal by simply noting that its hands are tied: it cannot act because we don't know about the potential effects of a contraband menthol cigarette market.
Lastly, the TSPAC report not only delays a potential menthol ban by years, but in doing so, takes the wind out of the sails of advocates who have been pushing for such a ban. The issue is going to be lost among the many other things that the FDA considers in the upcoming years, and the chance that the public health community had to advocate for such a policy has been squandered.
By the way, this is exactly the way the process is supposed to work. By exempting menthol from the Tobacco Act's flavoring ban and instead, appointing a committee to "study" the problem, Congress (and sadly, the Campaign for Tobacco-Free Kids) got exactly what they intended: the exemption of menthol cigarettes so that there would be no substantial reduction in cigarette profits, thus retaining Philip Morris' support for the legislation and keeping the negotiated deal in tact.
This was made easier because it was the health of the African American community that was offered to Philip Morris as a bargaining chip. It's a lot easier to trade away the rights and interests of marginalized communities - especially communities of color - with less political power. If the interests of white males were at stakes, things would have looked very different.
Sadly, as Bob Robinson was the first to point out and constantly reminds us, it is not the tobacco companies but the Campaign for Tobacco-Free Kids which was the first to jump forward with the argument that menthol cigarettes need to remain on the market because of the potential of a contraband market if they are banned. With friends like the Campaign for Tobacco-Free Kids, Lorillard did not even need to do its own advocacy work to protect its menthol cigarette sales. The Campaign did the dirty work for them.
Last week, Senator Richard Blumenthal wrote to the FDA seeking a ban on menthol cigarettes. In response, however, the Center for Regulatory Effectiveness (CRE) - citing TPSAC's own report - noted that the FDA cannot ban menthol cigarettes until a study is carried out on the issue of contraband cigarettes that could arise if menthol cigarettes are banned.
According to CRE's press release: "Senator Blumenthal states that his recommendation to ban menthol cigarettes is based on the report of the FDA Tobacco Product Scientific Advisory Committee. Unfortunately he must have not read the report in its entirety. The TPSAC made it clear that no action can be taken on a ban until the issue of contraband has been addressed."
The Rest of the Story
The Center for Regulatory Effectiveness is absolutely correct. The TPSAC's report, rather than recommend a ban on menthol, actually cautioned against such a ban, requesting that the FDA conduct a study of the contraband issue before embracing any particular policy regarding menthol.
Nevertheless, the chair of the TPSAC panel told the media that the Committee did in fact make a clear recommendation. This flies in the face of the clear language of the TPSAC's report.
The rest of the story is that rather than offer a recommendation, TPSAC punted the issue back to the FDA and shirked its responsibility. The Committee was statutorily charged with making a recommendation to the FDA about whether to ban menthol cigarettes, taking into account the issue of potential contraband. The Committee failed to carry out this charge.
At the end of the day, all the TPSAC menthol report actually does is put an even larger hurdle in the path of a potential menthol cigarette ban. It delays any such policy by years, requiring the FDA [unless the Agency ignores the report] to conduct a contraband study before even proposing a policy. Most importantly, it gives the Agency an out whereby it can respond to politicians like Blumenthal by simply noting that its hands are tied: it cannot act because we don't know about the potential effects of a contraband menthol cigarette market.
Lastly, the TSPAC report not only delays a potential menthol ban by years, but in doing so, takes the wind out of the sails of advocates who have been pushing for such a ban. The issue is going to be lost among the many other things that the FDA considers in the upcoming years, and the chance that the public health community had to advocate for such a policy has been squandered.
By the way, this is exactly the way the process is supposed to work. By exempting menthol from the Tobacco Act's flavoring ban and instead, appointing a committee to "study" the problem, Congress (and sadly, the Campaign for Tobacco-Free Kids) got exactly what they intended: the exemption of menthol cigarettes so that there would be no substantial reduction in cigarette profits, thus retaining Philip Morris' support for the legislation and keeping the negotiated deal in tact.
This was made easier because it was the health of the African American community that was offered to Philip Morris as a bargaining chip. It's a lot easier to trade away the rights and interests of marginalized communities - especially communities of color - with less political power. If the interests of white males were at stakes, things would have looked very different.
Sadly, as Bob Robinson was the first to point out and constantly reminds us, it is not the tobacco companies but the Campaign for Tobacco-Free Kids which was the first to jump forward with the argument that menthol cigarettes need to remain on the market because of the potential of a contraband market if they are banned. With friends like the Campaign for Tobacco-Free Kids, Lorillard did not even need to do its own advocacy work to protect its menthol cigarette sales. The Campaign did the dirty work for them.
Tuesday, April 26, 2011
FDA Accepts Appeals Court Ruling; Will Regulate Electronic Cigarettes as Tobacco Products
The Food and Drug Administration (FDA) announced yesterday that it will accept the ruling of the D.C. Court of Appeals and regulate electronic cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act, rather than as drug-device combinations under the Food, Drug, and Cosmetic Act, as long as the manufacturers do not make therapeutic claims.
The FDA plans to issue specific regulations and guidances regarding electronic cigarettes that will clarify exactly how the Agency plans to deal with these products under the Tobacco Act. One major potential guidance is how the Agency will interpret the term "therapeutic claims" with regards to electronic cigarettes.
The FDA wrote: "The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes. The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera."
An important detail that the FDA spelled out yesterday was that the Tobacco Act grandfathers in only products that were on the market as of February 15, 2007 or which are substantially equivalent to such products: "'Tobacco products' marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent."
The Rest of the Story
The implications of the FDA's action depend largely on how the Agency chooses to implement the regulation of electronic cigarettes. Therefore, many of the implications of the action are unclear. Below, I have tried to articulate what we definitely know and what we don't know at this point.
What We Know
1. Most importantly, electronic cigarettes will be regulated as tobacco products under the Tobacco Act. The most critical implication of this fact is that these products will not be completely removed from the market. Electronic cigarettes will remain available, which is of tremendous public health significance as many vapers are using these products to stay off of tobacco cigarettes.
2. Electronic cigarette companies will remain free from regulation under the Food, Drug, and Cosmetic Act as long as they refrain from making therapeutic claims. Electronic cigarette companies can safely market electronic cigarettes as smoking alternatives without running afoul of the FDA's guidance.
3. Electronic cigarette companies will need to refrain from making therapeutic claims, unless they put their products through the drug approval process. While the FDA has yet to issue guidance as to what a "therapeutic claim" means with regard to electronic cigarettes, it is clear that electronic cigarette companies cannot claim that these products are intended to treat any disease, such as smoking addiction. No claim can be made that the product will treat nicotine withdrawal symptoms. What is not clear is whether a claim that the product can help a person quit smoking would be considered a therapeutic claim (see below).
4. Electronic cigarette companies will not be able to claim that these products are safer than smoking. While this is ridiculous because there is no question that these products are safer than tobacco cigarettes, it is - unfortunately - the law. This is in fact one of the major reasons why I opposed the Family Smoking Prevention and Tobacco Control Act in the first place. I have written extensively about why the modified risk provisions of the Tobacco Act are antithetical to public health goals. Nevertheless, the law is the law and electronic cigarette companies will not be able to tell the public of the chief benefit of these products: that they are safer than regular cigarettes. Of course, that doesn't stop others - outside of the industry (such as myself) - from informing the public about the relative safety of electronic cigarettes compared to regular ones. It also doesn't stop electronic cigarette companies from submitting an application to the FDA to have their products approved as reduced risk products. But it is unclear what evidence would be required to achieve such a designation.
5. Some brands of electronic cigarettes could potentially be pulled off the market. It all depends on how the FDA interprets the phrase "substantially similar." Electronic cigarettes that were on the market as of February 15, 2007 are fine. But brands introduced subsequent to that date could be determined to be "new" products and would therefore need approval by the FDA. It is unclear whether companies could successfully obtain such approval. On the other hand, all electronic cigarettes are quite similar, and it is also possible that companies could successfully argue that their brands are "substantially similar" to brands that were on the market as of February 15, 2007.
6. All electronic cigarette companies will have to comply with certain blanket requirements, such as registration of their products, disclosure of ingredients, and good manufacturing practices. Companies may also be subject to user fees to help defray the cost of regulation.
What We Don't Know
1. How will the FDA interpret "substantially equivalent" regarding electronic cigarettes? Since all electronic cigarettes are basically very similar, it could be that they are all substantially equivalent to products on the market as of February 15, 2007, and that all brands can therefore remain on the market. But it is unclear whether that is the approach that the FDA will take.
2. How will the FDA interpret "therapeutic claims" regarding electronic cigarettes? The key question is whether stating that these products can help people quit smoking represents a therapeutic claim. Elsewhere, I have argued that such a claim is not a therapeutic claim because smoking is not a disease, but a behavior." Unless companies state that the product is intended to prevent nicotine withdrawal symptoms, then they are not making a therapeutic claim. But it is not at all clear whether the FDA will accept this interpretation.
3. Would the FDA approve an electronic cigarette brand not on the market as of February 15, 2007 as a new tobacco product? If the FDA does not allow brands that were not on the market as of February 15, 2007 to be grandfathered in as "substantially equivalent" products, will the Agency approve them as new products? For this to happen, the company would have to demonstrate that these products would benefit the public's health. I think there is sufficient evidence to make such a claim, but will the FDA?
4. Will the FDA approve reduced risk claims for electronic cigarettes? It is clear that electronic cigarette companies cannot continue to make reduced risk claims because their products would then violate the Modified Risk provisions of the Tobacco Act. However, the question is whether they could successfully apply for modified risk designation. I believe there is sufficient evidence to support such a designation, but will the FDA?
Conclusions
All in all, this is a good thing for the public's health. Regulating electronic cigarettes under the Food, Drug, and Cosmetic Act would essentially remove these products from the market, causing tremendous harm to current and potential future users of these products. Regulating electronic cigarettes under the Tobacco Act is appropriate and ensures that they will remain available to smokers who want to quit and to ex-smokers who have already quit using these products
Just how beneficial this is for the public's health will depend on how the FDA answers the four questions above. How stringent or lenient will the Agency be in interpreting the meaning of "substantially equivalent" and "therapeutic claim" with regard to electronic cigarettes under the Tobacco Act and how much evidence will the Agency require for companies to successfully obtain a designation of their products as being "reduced risk" products?
I will continue to follow this issue and report on any regulations or guidances that the FDA issues.
The FDA plans to issue specific regulations and guidances regarding electronic cigarettes that will clarify exactly how the Agency plans to deal with these products under the Tobacco Act. One major potential guidance is how the Agency will interpret the term "therapeutic claims" with regards to electronic cigarettes.
The FDA wrote: "The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes. The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera."
An important detail that the FDA spelled out yesterday was that the Tobacco Act grandfathers in only products that were on the market as of February 15, 2007 or which are substantially equivalent to such products: "'Tobacco products' marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent."
The Rest of the Story
The implications of the FDA's action depend largely on how the Agency chooses to implement the regulation of electronic cigarettes. Therefore, many of the implications of the action are unclear. Below, I have tried to articulate what we definitely know and what we don't know at this point.
What We Know
1. Most importantly, electronic cigarettes will be regulated as tobacco products under the Tobacco Act. The most critical implication of this fact is that these products will not be completely removed from the market. Electronic cigarettes will remain available, which is of tremendous public health significance as many vapers are using these products to stay off of tobacco cigarettes.
2. Electronic cigarette companies will remain free from regulation under the Food, Drug, and Cosmetic Act as long as they refrain from making therapeutic claims. Electronic cigarette companies can safely market electronic cigarettes as smoking alternatives without running afoul of the FDA's guidance.
3. Electronic cigarette companies will need to refrain from making therapeutic claims, unless they put their products through the drug approval process. While the FDA has yet to issue guidance as to what a "therapeutic claim" means with regard to electronic cigarettes, it is clear that electronic cigarette companies cannot claim that these products are intended to treat any disease, such as smoking addiction. No claim can be made that the product will treat nicotine withdrawal symptoms. What is not clear is whether a claim that the product can help a person quit smoking would be considered a therapeutic claim (see below).
4. Electronic cigarette companies will not be able to claim that these products are safer than smoking. While this is ridiculous because there is no question that these products are safer than tobacco cigarettes, it is - unfortunately - the law. This is in fact one of the major reasons why I opposed the Family Smoking Prevention and Tobacco Control Act in the first place. I have written extensively about why the modified risk provisions of the Tobacco Act are antithetical to public health goals. Nevertheless, the law is the law and electronic cigarette companies will not be able to tell the public of the chief benefit of these products: that they are safer than regular cigarettes. Of course, that doesn't stop others - outside of the industry (such as myself) - from informing the public about the relative safety of electronic cigarettes compared to regular ones. It also doesn't stop electronic cigarette companies from submitting an application to the FDA to have their products approved as reduced risk products. But it is unclear what evidence would be required to achieve such a designation.
5. Some brands of electronic cigarettes could potentially be pulled off the market. It all depends on how the FDA interprets the phrase "substantially similar." Electronic cigarettes that were on the market as of February 15, 2007 are fine. But brands introduced subsequent to that date could be determined to be "new" products and would therefore need approval by the FDA. It is unclear whether companies could successfully obtain such approval. On the other hand, all electronic cigarettes are quite similar, and it is also possible that companies could successfully argue that their brands are "substantially similar" to brands that were on the market as of February 15, 2007.
6. All electronic cigarette companies will have to comply with certain blanket requirements, such as registration of their products, disclosure of ingredients, and good manufacturing practices. Companies may also be subject to user fees to help defray the cost of regulation.
What We Don't Know
1. How will the FDA interpret "substantially equivalent" regarding electronic cigarettes? Since all electronic cigarettes are basically very similar, it could be that they are all substantially equivalent to products on the market as of February 15, 2007, and that all brands can therefore remain on the market. But it is unclear whether that is the approach that the FDA will take.
2. How will the FDA interpret "therapeutic claims" regarding electronic cigarettes? The key question is whether stating that these products can help people quit smoking represents a therapeutic claim. Elsewhere, I have argued that such a claim is not a therapeutic claim because smoking is not a disease, but a behavior." Unless companies state that the product is intended to prevent nicotine withdrawal symptoms, then they are not making a therapeutic claim. But it is not at all clear whether the FDA will accept this interpretation.
3. Would the FDA approve an electronic cigarette brand not on the market as of February 15, 2007 as a new tobacco product? If the FDA does not allow brands that were not on the market as of February 15, 2007 to be grandfathered in as "substantially equivalent" products, will the Agency approve them as new products? For this to happen, the company would have to demonstrate that these products would benefit the public's health. I think there is sufficient evidence to make such a claim, but will the FDA?
4. Will the FDA approve reduced risk claims for electronic cigarettes? It is clear that electronic cigarette companies cannot continue to make reduced risk claims because their products would then violate the Modified Risk provisions of the Tobacco Act. However, the question is whether they could successfully apply for modified risk designation. I believe there is sufficient evidence to support such a designation, but will the FDA?
Conclusions
All in all, this is a good thing for the public's health. Regulating electronic cigarettes under the Food, Drug, and Cosmetic Act would essentially remove these products from the market, causing tremendous harm to current and potential future users of these products. Regulating electronic cigarettes under the Tobacco Act is appropriate and ensures that they will remain available to smokers who want to quit and to ex-smokers who have already quit using these products
Just how beneficial this is for the public's health will depend on how the FDA answers the four questions above. How stringent or lenient will the Agency be in interpreting the meaning of "substantially equivalent" and "therapeutic claim" with regard to electronic cigarettes under the Tobacco Act and how much evidence will the Agency require for companies to successfully obtain a designation of their products as being "reduced risk" products?
I will continue to follow this issue and report on any regulations or guidances that the FDA issues.
Monday, April 25, 2011
Can the Government Ban Hypocrisy? Why Pharmacy Tobacco Sales Bans are Not Justified
According to an article in yesterday's Boston Globe, pharmacy tobacco sales bans are spreading across Massachusetts, with nine cities and towns have enacted such policies in the past three years. The justification for these policies, as expressed by one of the town's tobacco control coordinators, is that the laws are necessary to prevent the hypocrisy of stores selling healthful products and cigarettes at the same time.
According to the article: "The pace of Massachusetts cities and towns banning tobacco sales at pharmacies appears to be accelerating: Of nine such bans that have taken effect since early 2009, four began this year, and more are under consideration. South of Boston, Sharon defeated a proposed ban April 11, but the Wareham Board of Health may opt for one, according to Bob Collett, director the Cape Cod Regional Tobacco Control Program. Collett made a presentation to the Wareham board recently. 'I’m confident that it will happen there,' he said. 'They do understand the obvious hypocrisy of selling tobacco in a health care setting such as a pharmacy, and they have supported tobacco control efforts in the past.'"
The Rest of the Story
I just don't see how government intervention is justified for the purpose of preventing hypocrisy. If that were the case, it would justify a slew of laws to regulate the behavior of tobacco control groups. For the Campaign for Tobacco-Free Kids alone, there would be about 25 laws on the books.
Yes, it is hypocritical for pharmacies that market themselves as being part of the health care establishment to also sell cigarettes. But it is far more hypocritical for policy makers to send the message that selling cigarettes in pharmacies is bad, while selling them in gas stations and convenience stores is just fine.
Preventing hypocrisy is not a legitimate justification for government intervention into private businesses. I find it highly hypocritical for corporations like Coca-Cola to contribute money to organizations like the American Dietetic Association. That is highly hypocritical, but there is no justification for a government law to prevent such contributions. It is hypocritical for Boston University to host Charlie Sheen for his side-show, but enacting a law to tell the University it can't do that is not warranted. It seems hypocritical for Burger King to sell Whoppers alongside fresh salads, but it doesn't justify a government law to regulate the foods that Burger King can and cannot sell.
Government intervention is justified to prevent the public from health hazards. But the sale of tobacco in pharmacies is not a health hazard. The health hazard is the sale of tobacco, period. In fact, pharmacy sales bans define the problem in the wrong way. They frame the problem as the sale of tobacco in certain types of stores. That's not the problem. The problem is that the products, wherever they are sold, are toxic and addictive.
In the long run, I believe that the focus on pharmacy cigarette sales ban is harming, more than helping the tobacco control cause. Why? Because:
1. These policies do nothing to protect the public's health. They will not reduce the sale of tobacco to minors, because kids will simply buy their cigarettes elsewhere. In fact, most kids don't buy their cigarettes in pharmacies to begin with.
2. These policies frame the issue in exactly the wrong way. They send the message that the sale of cigarettes is perfectly fine, as long as you don't also sell pharmaceutical products. They take the focus off the actual issue at hand, which is that cigarettes are a deadly product, no matter where they are sold.
According to the article: "The pace of Massachusetts cities and towns banning tobacco sales at pharmacies appears to be accelerating: Of nine such bans that have taken effect since early 2009, four began this year, and more are under consideration. South of Boston, Sharon defeated a proposed ban April 11, but the Wareham Board of Health may opt for one, according to Bob Collett, director the Cape Cod Regional Tobacco Control Program. Collett made a presentation to the Wareham board recently. 'I’m confident that it will happen there,' he said. 'They do understand the obvious hypocrisy of selling tobacco in a health care setting such as a pharmacy, and they have supported tobacco control efforts in the past.'"
The Rest of the Story
I just don't see how government intervention is justified for the purpose of preventing hypocrisy. If that were the case, it would justify a slew of laws to regulate the behavior of tobacco control groups. For the Campaign for Tobacco-Free Kids alone, there would be about 25 laws on the books.
Yes, it is hypocritical for pharmacies that market themselves as being part of the health care establishment to also sell cigarettes. But it is far more hypocritical for policy makers to send the message that selling cigarettes in pharmacies is bad, while selling them in gas stations and convenience stores is just fine.
Preventing hypocrisy is not a legitimate justification for government intervention into private businesses. I find it highly hypocritical for corporations like Coca-Cola to contribute money to organizations like the American Dietetic Association. That is highly hypocritical, but there is no justification for a government law to prevent such contributions. It is hypocritical for Boston University to host Charlie Sheen for his side-show, but enacting a law to tell the University it can't do that is not warranted. It seems hypocritical for Burger King to sell Whoppers alongside fresh salads, but it doesn't justify a government law to regulate the foods that Burger King can and cannot sell.
Government intervention is justified to prevent the public from health hazards. But the sale of tobacco in pharmacies is not a health hazard. The health hazard is the sale of tobacco, period. In fact, pharmacy sales bans define the problem in the wrong way. They frame the problem as the sale of tobacco in certain types of stores. That's not the problem. The problem is that the products, wherever they are sold, are toxic and addictive.
In the long run, I believe that the focus on pharmacy cigarette sales ban is harming, more than helping the tobacco control cause. Why? Because:
1. These policies do nothing to protect the public's health. They will not reduce the sale of tobacco to minors, because kids will simply buy their cigarettes elsewhere. In fact, most kids don't buy their cigarettes in pharmacies to begin with.
2. These policies frame the issue in exactly the wrong way. They send the message that the sale of cigarettes is perfectly fine, as long as you don't also sell pharmaceutical products. They take the focus off the actual issue at hand, which is that cigarettes are a deadly product, no matter where they are sold.
Friday, April 22, 2011
World Medical Association Wants to Ban Electronic and Candy Cigarettes, and Keep the Real Ones; Claims that E-Cigs are Tobacco Industry Ploy
According to a press release issued by the World Medical Association (WMA), the WMA wants to ban candy and electronic cigarettes, while keeping the real ones.
Also, according to the press release, the American Medical Association claimed that the tobacco industry is aggressively marketing electronic cigarettes.
The press release states: "The World Medical Association will step up its fight against smoking with proposals to ban the production, distribution and sale of candy products that depict or resemble tobacco products. At their three-day Council meeting in Sydney, Australia, (April 7-9) WMA delegates agreed to recommend to their annual Assembly in October plans to strengthen the organisation's anti tobacco policy to combat moves by the tobacco industry to make their products more appealing to young people. Delegates argued that the WMA should extend its policy to include restrictions on smokeless tobacco and tobacco-derived products, including prohibiting all government subsidies for tobacco-derived products. Dr. Ardis Hoven, chair of the Board of the American Medical Association, said the tobacco industry was now involved in aggressively promoting new forms of cigarettes, such as smokeless tobacco and electronic cigarettes in shops and on the internet to attract and appeal to young people, and the WMA needed to respond strongly."
The Rest of the Story
The Medical Association is telling a blatant lie. Tobacco companies have nothing to do with electronic cigarettes. They neither produce nor market these products.
The rest of the story, then, is that the Medical Association is lying. The problem is, it's not clear exactly which Medical Association is lying.
Either the American Medical Association is lying, or the World Medical Association is lying.
The Western Medical Association claims that the American Medical Association chair told the audience that tobacco companies are aggressively marketing electronic cigarettes. So there are two possibilities:
1. The American Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did actually make this claim.
2. The Western Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did not actually make this claim.
Either way, a physician's organization is lying to the public in order to cast electronic cigarettes in a negative light, and thus encourage smokers to stick with regular cigarettes and ex-smokers who have quit by virtue of e-cigs to return to tobacco cigarettes.
Moreover, it appears that both the World Medical Association and the American Medical Association are trying to eliminate the safer alternatives to cigarette smoking, while protecting existing cigarettes from any serious competition and ensuring that the hundreds of thousands of people who are using electronic cigarettes to help quit smoking will be forced to return to their Marlboros, Camels, Newports, Kools, and Salems.
Why are these physician organizations acting to protect the profits of cigarette companies at the expense of the public's health?
And why are they lying to the public in order to achieve that result?
While blatantly lying to the public would be bad enough, lying in a way that is going to encourage people to use a far more harmful product than a safer one is particularly egregious.
Also, according to the press release, the American Medical Association claimed that the tobacco industry is aggressively marketing electronic cigarettes.
The press release states: "The World Medical Association will step up its fight against smoking with proposals to ban the production, distribution and sale of candy products that depict or resemble tobacco products. At their three-day Council meeting in Sydney, Australia, (April 7-9) WMA delegates agreed to recommend to their annual Assembly in October plans to strengthen the organisation's anti tobacco policy to combat moves by the tobacco industry to make their products more appealing to young people. Delegates argued that the WMA should extend its policy to include restrictions on smokeless tobacco and tobacco-derived products, including prohibiting all government subsidies for tobacco-derived products. Dr. Ardis Hoven, chair of the Board of the American Medical Association, said the tobacco industry was now involved in aggressively promoting new forms of cigarettes, such as smokeless tobacco and electronic cigarettes in shops and on the internet to attract and appeal to young people, and the WMA needed to respond strongly."
The Rest of the Story
The Medical Association is telling a blatant lie. Tobacco companies have nothing to do with electronic cigarettes. They neither produce nor market these products.
The rest of the story, then, is that the Medical Association is lying. The problem is, it's not clear exactly which Medical Association is lying.
Either the American Medical Association is lying, or the World Medical Association is lying.
The Western Medical Association claims that the American Medical Association chair told the audience that tobacco companies are aggressively marketing electronic cigarettes. So there are two possibilities:
1. The American Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did actually make this claim.
2. The Western Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did not actually make this claim.
Either way, a physician's organization is lying to the public in order to cast electronic cigarettes in a negative light, and thus encourage smokers to stick with regular cigarettes and ex-smokers who have quit by virtue of e-cigs to return to tobacco cigarettes.
Moreover, it appears that both the World Medical Association and the American Medical Association are trying to eliminate the safer alternatives to cigarette smoking, while protecting existing cigarettes from any serious competition and ensuring that the hundreds of thousands of people who are using electronic cigarettes to help quit smoking will be forced to return to their Marlboros, Camels, Newports, Kools, and Salems.
Why are these physician organizations acting to protect the profits of cigarette companies at the expense of the public's health?
And why are they lying to the public in order to achieve that result?
While blatantly lying to the public would be bad enough, lying in a way that is going to encourage people to use a far more harmful product than a safer one is particularly egregious.
Thursday, April 21, 2011
American Dietetic Association, American Academy of Pediatrics and Other Health Groups Have Compromised Their Integrity by Accepting Big Food Money
By Partnering With These Corporations, Health Groups Are Actually Working Against the Public's Health
The American Academy of Pediatrics is publicly stating that the Coca-Cola Company is committed "to better the health of children worldwide."
The American Dietetic Association publicly states that the Coca-Cola Company shares its position and policies.
Let's now examine each of these two statements.
The Rest of the Story
1. The American Academy of Pediatrics
Let's examine what it means when the American Academy of Pediatrics states that Coca-Cola is a leader in the movement to improve the health of children worldwide.
What it means is that to improve the health of children worldwide, you can do the following things:
- oppose bills in almost every state to restrict the sale of soda and junk food in schools;
- oppose bills in almost every state to set school nutrition standards;
- send lobbyists to almost every state to defeat or weaken legislation to improve child nutrition; and
- deny the scientific evidence that soda contributes to obesity.
Simon writes (page 223): "The GMA is on record as opposing virtually every state bill across the nation that would restrict the sale of junk food or soda in schools. A search for the word "schools" on the GMA Web site resulted in no fewer than 126 hits, most of which are either submitted testimony or a letter filed in opposition to a school-related nutrition policy. Here are just a few examples of document titles: GMA Letter in Opposition of Texas Food and Beverage Restrictions, GMA Letter in Opposition to Oregon School Restrictions Bill, GMA Requests Veto of Kentucky School Restrictions Bill, and GMA Letter in Opposition to California School Nutrition Bill."
Simon continues (page 222-224): "GMA does more than just write letters; the group also has resources to send lobbyists to every state capital in the nation to defeat or weaken legislation. This high-powered lobbying campaign is quite effective. For example, in 2004, GMA helped defeat a California bill that would have set nutrition standards on school food. At every step along the way, the GMA and its member companies have beat nutrition advocates back because they have more lobbying resources, not to mention money to offer politicians in the form of campaign contributions."
Simon concludes (page 224) that "the soda industry is well represented by high-powered lobbyists and regional bottling associations. When it comes to school nutrition, the one company that emerges as the worst corporate actor is Coca-Cola. While other companies also lobby, Coca-Cola puts up the biggest fight and in the nastiest ways. The general rule of thumb that companies like to leave the dirty work to trade groups does not seem to apply to Coke's lobbyists."
Simon's book also reveals that the soft drink industry lobbies against public health legislation deceptively, without even disclosing their affiliation, and that soft drink lobbyists often refute scientific data which clearly show an association between soda consumption and obesity. She writes (page 225): "The soda industry also sent paid consultants to testify at hearings on Philadelphia's districtwide policy without revealing their affiliation. These experts presented industry-sponsored data to show that soda does not cause obesity."
Perhaps most troubling, Simon reveals that Coca-Cola has contributed money which went towards personal attacks against nutrition advocates. Some attacks were horrific, even going to the point of making homophobic statements (page 226).
Why is the American Academy of Pediatrics arguing that the company which is doing all of these things to oppose the protection of the public's health is committed "to better the health of children worldwide"? Why would the American Academy of Pediatrics choose to partner with this company?
Moreover, by touting Coca-Cola as a leader in the effort to improve children's health, I would argue that the American Academy of Pediatrics is not only compromising its integrity, but it is actually working against the public health, because it is undermining efforts to promote policies to improve school nutrition and improve the health of children and adolescents.
The answer, unfortunately, is money. The American Academy of Pediatrics is now bought and paid for by Coca-Cola. Money speaks, and if you pay enough of it, you can even buy off the nation's pediatricians.
2. The American Dietetic Association
Let's examine what it means when the American Dietetic Association states that Coca-Cola shares its positions and policies.
What it means is that the ADA's position and policies must (by logical reasoning) be the following:
- oppose bills in almost every state to restrict the sale of soda and junk food in schools;
- oppose bills in almost every state to set school nutrition standards;
- send lobbyists to almost every state to defeat or weaken legislation to improve child nutrition; and
- deny the scientific evidence that soda contributes to obesity.
Moreover, by touting Coca-Cola as a leader in the effort to improve children's health, I would argue that the American Dietetic Association is not only compromising its integrity, but it is actually working against the public health, because it is undermining efforts to promote policies to improve school nutrition and improve the health of children and adolescents.
The answer, unfortunately, is money. The American Dietetic Association is now bought and paid for by Coca-Cola. Money speaks, and if you pay enough of it, you can even buy off the nation's nutritionists.
The rest of the story is that the American Academy of Pediatrics and American Dietetic Association (along with the American Academy of Family Physicians and American Cancer Society) should have new slogans to accurate reflect their actions and priorities. I suggest:
The American Academy of Pediatrics: Bought and Paid for by the Coca-Cola Company
The American Dietetic Association: The Chicago Branch of the Coca-Cola Corporation
Wednesday, April 20, 2011
Tobacco Act's Ban on Low Yield Descriptors Has Had No Effect, New Study Shows
The health groups which supported the Family Smoking Prevention and Tobacco Control Act boasted that one of the great public health benefits of the legislation was that it would save lives by eliminating low yield cigarette descriptors such as "low-tar," "light," and "mild." Smokers would no longer be deceived into thinking that these low-yield cigarettes were safer than others.
The Campaign for Tobacco-Free Kids told the public that the ban on low yield descriptors was "one of the most significant provisions of the law." It asserted that this provision would "prevent tobacco industry deception about tar [and] nicotine levels."
The Rest of the Story
As I predicted years ago, the ban on low yield descriptors has now been shown to have no effect because cigarette companies simply substituted packaging colors to indicate what previously were the low-yield brands. For example, Marlboro Lights are now Marlboro Gold. Moreover, the research shows that smokers understand that these colors represent the low-yield brands and that they still believe that these brands convey lower health risks.
According to a press release summarizing the study findings: "Despite current prohibitions on the words 'light' and 'mild', smokers in Western countries continue falsely to believe that some cigarette brands may be less harmful than others. ... A study published today in the journal Addiction polled over 8000 smokers from Australia, Canada, the United Kingdom and the USA. Approximately one-fifth of those smokers incorrectly believed that "some cigarette brands could be less harmful than others." False beliefs were highest among US smokers. Current research shows that smokers base their perceptions of risk on pack colour, believing that 'silver', 'gold' and 'white' brands are less harmful to smoke than 'black' or 'red' brands. The reason for those beliefs may lie in the history of cigarette branding. Cigarettes used to carry labels like 'light', 'mild', and 'low tar', and in some places they still do. But in over fifty countries cigarette manufacturers are no longer allowed to use those labels because they are misleading. In some cases, cigarette manufacturers simply changed their 'light' cigarettes to 'silver' and 'gold' brands -- for example, Marlboro Lights has become Marlboro Gold. A significant percentage of smokers now seem to equate those colours with low-risk cigarettes."
According to the Campaign for Tobacco-Free Kids, two of the major public health victories from the passage of the FDA tobacco legislation -- which were supposed to save "countless lives" -- were the ban on flavored cigarettes and the ban on the use of descriptors like "light" and "low-tar" that mislead consumers into believing that these cigarettes are safer.
But one by one, these (false) promises have come tumbling to the ground.
First, it was the promise that the ban on flavored cigarettes would break the cycle of addiction by helping to end the tobacco industry's ability to addict our nation's children. The Campaign wrote that: "The ban on candy and fruit-flavored cigarettes is a critical step to end one of the most insidious tactics the tobacco industry has used to target and addict children."
But the truth came out: not a single product produced by Philip Morris, R.J. Reynolds, or Lorillard was affected by the cigarette flavoring ban, very few youths smoke products that are affected by the ban, and in the entire cigarette market, less than 0.2% of all cigarettes consumed are flavored cigarettes covered by the ban. The truth is that far from being a critical step to halt addiction, this aspect of the law does literally nothing to protect kids from addiction.
Now, it is the promise that the ban on descriptors such as "light" and "low-tar" will eliminate the deception of consumers, who are led to believe that these products are safer because of this terminology.
So far, the Family Smoking Prevention and Tobacco Control Act has not done a single thing to substantially protect the public's health. It has done nothing to reduce youth smoking. It has done nothing to promote smoking cessation. And it has done nothing to make cigarettes safer.
It has, however, detracted attention and resources away from the proven measures that would have helped protect the public's health and actually save lives: allocating money to anti-smoking media campaigns in all 50 states.
Perhaps second only to the Master Settlement Agreement, I believe that the Family Smoking Prevention and Tobacco Control Act represents one of the greatest public health policy disasters of my lifetime.
The Campaign for Tobacco-Free Kids told the public that the ban on low yield descriptors was "one of the most significant provisions of the law." It asserted that this provision would "prevent tobacco industry deception about tar [and] nicotine levels."
The Rest of the Story
As I predicted years ago, the ban on low yield descriptors has now been shown to have no effect because cigarette companies simply substituted packaging colors to indicate what previously were the low-yield brands. For example, Marlboro Lights are now Marlboro Gold. Moreover, the research shows that smokers understand that these colors represent the low-yield brands and that they still believe that these brands convey lower health risks.
According to a press release summarizing the study findings: "Despite current prohibitions on the words 'light' and 'mild', smokers in Western countries continue falsely to believe that some cigarette brands may be less harmful than others. ... A study published today in the journal Addiction polled over 8000 smokers from Australia, Canada, the United Kingdom and the USA. Approximately one-fifth of those smokers incorrectly believed that "some cigarette brands could be less harmful than others." False beliefs were highest among US smokers. Current research shows that smokers base their perceptions of risk on pack colour, believing that 'silver', 'gold' and 'white' brands are less harmful to smoke than 'black' or 'red' brands. The reason for those beliefs may lie in the history of cigarette branding. Cigarettes used to carry labels like 'light', 'mild', and 'low tar', and in some places they still do. But in over fifty countries cigarette manufacturers are no longer allowed to use those labels because they are misleading. In some cases, cigarette manufacturers simply changed their 'light' cigarettes to 'silver' and 'gold' brands -- for example, Marlboro Lights has become Marlboro Gold. A significant percentage of smokers now seem to equate those colours with low-risk cigarettes."
According to the Campaign for Tobacco-Free Kids, two of the major public health victories from the passage of the FDA tobacco legislation -- which were supposed to save "countless lives" -- were the ban on flavored cigarettes and the ban on the use of descriptors like "light" and "low-tar" that mislead consumers into believing that these cigarettes are safer.
But one by one, these (false) promises have come tumbling to the ground.
First, it was the promise that the ban on flavored cigarettes would break the cycle of addiction by helping to end the tobacco industry's ability to addict our nation's children. The Campaign wrote that: "The ban on candy and fruit-flavored cigarettes is a critical step to end one of the most insidious tactics the tobacco industry has used to target and addict children."
But the truth came out: not a single product produced by Philip Morris, R.J. Reynolds, or Lorillard was affected by the cigarette flavoring ban, very few youths smoke products that are affected by the ban, and in the entire cigarette market, less than 0.2% of all cigarettes consumed are flavored cigarettes covered by the ban. The truth is that far from being a critical step to halt addiction, this aspect of the law does literally nothing to protect kids from addiction.
Now, it is the promise that the ban on descriptors such as "light" and "low-tar" will eliminate the deception of consumers, who are led to believe that these products are safer because of this terminology.
So far, the Family Smoking Prevention and Tobacco Control Act has not done a single thing to substantially protect the public's health. It has done nothing to reduce youth smoking. It has done nothing to promote smoking cessation. And it has done nothing to make cigarettes safer.
It has, however, detracted attention and resources away from the proven measures that would have helped protect the public's health and actually save lives: allocating money to anti-smoking media campaigns in all 50 states.
Perhaps second only to the Master Settlement Agreement, I believe that the Family Smoking Prevention and Tobacco Control Act represents one of the greatest public health policy disasters of my lifetime.
Tuesday, April 19, 2011
New Study Concludes that Secondhand Smoke Exposure Causes Mental Health Problems in Children, But Doesn't Control for Parental Mental Health Problems
A new study published in this month's issue of the Archives of Pediatrics and Adolescent Medicine concludes that secondhand smoke exposure among children causes mental illness, including depression, attention deficit disorder, and conduct disorder (see: Bandiera FC, Richardson AK, Lee, DJ, He J-P, Merikangas KR. Secondhand smoke exposure and mental health among children and adolescents. Archives of Pediatrics and Adolescent Medicine 2011; 165(4):332-338).
The research involved a cross-sectional study of the relationship between secondhand smoke exposure, measured by serum cotinine levels, and symptoms of mental illness based on data from the National Health and Nutrition Examination Survey in 2001 through 2004. The researchers found that: "Among nonsmokers, serum cotinine level was positively associated with symptoms of DSM-IV major depressive disorder, generalized anxiety disorder, attention-deficit/hyperactivity disorder, and conduct disorder after adjusting for survey design, age, sex, race/ethnicity, poverty, migraine, asthma, hay fever, maternal smoking during pregnancy, and allostatic load."
The article concludes: "The findings presented herein provide additional evidence on the harmful effects of SHS exposure on children and adolescents. Our results are consistent with data from previous cross-sectional and prospective studies in adults and suggest that exposure to SHS may precipitate the onset of or exacerbate mental disorder symptoms."
The Rest of the Story
The glaring limitation of this study is that it failed to control for mental health problems among the children's parents, which have been demonstrated to be associated both with smoking and with mental health problems among their children. Thus, this is a likely confounder of the observed association between secondhand smoke exposure and mental health problems among children and adolescents.
This flaw does not invalidate the overall finding of an association between secondhand smoke exposure and mental health problems in children, but it does preclude a conclusion that it is the secondhand smoke exposure that is causing the mental health problems. It may simply be that parents with mental health problems are both more likely to smoke and more likely to have children with mental health problems.
What is most striking about this article, however, is not any of the above. What is most striking is that the authors acknowledge this limitation, yet they still conclude that there is a causal relationship between secondhand smoke exposure and mental health problems in children.
The authors write: "Another potential confounder that we were unable to control for in our analysis is maternal psychiatric history. That is, children with depressed mothers are more likely to have poor mental health." They cite three studies which demonstrate an association between mental health problems in children and mental health problems in their mothers.
Despite this limitation, however, the authors go on to conclude that the association observed in the study is a causal one ("The findings presented herein provide additional evidence on the harmful effects of SHS exposure on children and adolescents.") In fact, they go so far as to suggest that if parents smoke outside the home, it will lower population rates of mental illness.
There is nothing wrong with publishing a study that has limitations. The art of research, however, is drawing solid conclusions given the limitations in your study. In this case, one wonders why the authors have drawn a causal conclusion despite the major limitation in the methodology, which they readily acknowledge and highlight for the reader. Unfortunately, it leaves the impression that the researchers had a pre-determined conclusion and that they reached this conclusion regardless of the strength of the actual scientific evidence.
As my readers know, this is not an isolated case. For some reason, many recent studies on secondhand smoke appear to fall into this category. For this reason, I have come to the conclusion that the scientific rigor in the tobacco control movement has deteriorated. Investigators seem so determined to demonstrate the adverse effects of secondhand smoke that they overlook their own clearly stated assertions and conclude that there is an effect of secondhand smoke anyway, despite their own acknowledgment that such a conclusion is unwarranted based on the evidence.
The research involved a cross-sectional study of the relationship between secondhand smoke exposure, measured by serum cotinine levels, and symptoms of mental illness based on data from the National Health and Nutrition Examination Survey in 2001 through 2004. The researchers found that: "Among nonsmokers, serum cotinine level was positively associated with symptoms of DSM-IV major depressive disorder, generalized anxiety disorder, attention-deficit/hyperactivity disorder, and conduct disorder after adjusting for survey design, age, sex, race/ethnicity, poverty, migraine, asthma, hay fever, maternal smoking during pregnancy, and allostatic load."
The article concludes: "The findings presented herein provide additional evidence on the harmful effects of SHS exposure on children and adolescents. Our results are consistent with data from previous cross-sectional and prospective studies in adults and suggest that exposure to SHS may precipitate the onset of or exacerbate mental disorder symptoms."
The Rest of the Story
The glaring limitation of this study is that it failed to control for mental health problems among the children's parents, which have been demonstrated to be associated both with smoking and with mental health problems among their children. Thus, this is a likely confounder of the observed association between secondhand smoke exposure and mental health problems among children and adolescents.
This flaw does not invalidate the overall finding of an association between secondhand smoke exposure and mental health problems in children, but it does preclude a conclusion that it is the secondhand smoke exposure that is causing the mental health problems. It may simply be that parents with mental health problems are both more likely to smoke and more likely to have children with mental health problems.
What is most striking about this article, however, is not any of the above. What is most striking is that the authors acknowledge this limitation, yet they still conclude that there is a causal relationship between secondhand smoke exposure and mental health problems in children.
The authors write: "Another potential confounder that we were unable to control for in our analysis is maternal psychiatric history. That is, children with depressed mothers are more likely to have poor mental health." They cite three studies which demonstrate an association between mental health problems in children and mental health problems in their mothers.
Despite this limitation, however, the authors go on to conclude that the association observed in the study is a causal one ("The findings presented herein provide additional evidence on the harmful effects of SHS exposure on children and adolescents.") In fact, they go so far as to suggest that if parents smoke outside the home, it will lower population rates of mental illness.
There is nothing wrong with publishing a study that has limitations. The art of research, however, is drawing solid conclusions given the limitations in your study. In this case, one wonders why the authors have drawn a causal conclusion despite the major limitation in the methodology, which they readily acknowledge and highlight for the reader. Unfortunately, it leaves the impression that the researchers had a pre-determined conclusion and that they reached this conclusion regardless of the strength of the actual scientific evidence.
As my readers know, this is not an isolated case. For some reason, many recent studies on secondhand smoke appear to fall into this category. For this reason, I have come to the conclusion that the scientific rigor in the tobacco control movement has deteriorated. Investigators seem so determined to demonstrate the adverse effects of secondhand smoke that they overlook their own clearly stated assertions and conclude that there is an effect of secondhand smoke anyway, despite their own acknowledgment that such a conclusion is unwarranted based on the evidence.
Monday, April 18, 2011
Can the Federal Government and a Health Charity Be Bought Off? Yes, Proves Coca-Cola
Consider this scenario:
You are a non-profit organization that is involved in lobbying all 50 state legislatures. You do not produce or market any products so you are not making any direct contribution to the nation's obesity problems. However, your lobbying efforts are directed against legislation to improve school nutrition standards, limit the availability of soda and junk food in schools, and reduce the consumption of junk food and soda.
You approach the National Heart, Lung, and Blood Institute (NHLBI) - nation's leading federal agency fighting heart disease (and therefore obesity) - and ask if you can be recognized by this federal agency as a partner in the national effort to reduce heart disease. You also approach the American Cancer Society with the same request.
Then, you go for broke. You ask the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to also endorse you as a full-fledged partner in the national effort to reduce childhood obesity.
When these organizations question you about your activities, you are honest and reveal that you actively lobby against legislation in all 50 states to improve school nutrition standards, limit the availability of soda and junk food in schools, and reduce the consumption of junk food and soda. You acknowledge that you are even lobbying against basic environmental health policies like bottle bills, which are supported by even the most conservative groups.
You also acknowledge that when advocates in one state attempted to set nutrition guidelines on food and beverages, you hired a lobbying firm to gut the law. "The political struggle included an eight-hour House debate in which lawmakers engaged in stall tactics and delayed the process by adding unrelated amendments. [Your] lobbyists also shared data regarding school income from soda sales with lawmakers behind closed doors so that nutrition advocates could not refute the information. [You] also delivered a well-stocked cooler [of Coca-Cola] to the Democratic caucus room just before the House was expected to vote on the bill." (Source: Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006)
In 2010 alone, you spent $4.9 million dollars lobbying against public health legislation, of which nearly a half million went to seven private lobbying firms. You also donated money to a front group which runs attack campaigns against public health and nutrition groups. The front group that you fund is run by an organization that also funds efforts to prevent stricter drunk driving legislation.
Do you think you would have a prayer in hell of ever getting the National Heart, Lung, and Blood Institute, the American Cancer Society, the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to endorse you as a full-fledged partner in the effort to fight childhood obesity and improve the public's health?
Probably not, but that isn't the actual scenario in question.
The actual scenario is as follows:
Everything above is true, including:
Now, if you didn't think you would have a prayer in hell of ever getting the National Heart, Lung, and Blood Institute, the American Cancer Society, the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to endorse you as a full-fledged partner in the effort to fight childhood obesity and improve the public's health before, what kind of chances do you think you'd have now?
On top of all your lobbying against policies to improve school nutrition and reduce junk food and soda consumption, on top of your millions of dollars of lobbying expenditures to fight public health and environmental health policies, and on top of your donations to an organization that is tied to even the most sensible policies like strict drunk driving laws, you are the leading producer of the actual soda that is contributing significantly to the obesity problem.
The Rest of the Story
The rest of the story is that this scenario actually occurred (see Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006), and that the corporation involved - the Coca-Cola Company - was successful in buying off the endorsements of the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians, as I detailed last week. In addition, as I reveal today, this corporation was successful in gaining similar endorsements and partnerships from the federal government - the National Heart, Lung, and Blood Institute (NHLBI) - and a health charity group: the American Cancer Society. Sadly, these organizations were also bought off by monetary donations, allowing Coca-Cola to achieve the unimaginable feat of opposing even basic school nutrition standards by being recognized by the NHLBI and the American Cancer Society as being a leader in the movement to reduce heart disease by controlling obesity.
1. The American Cancer Society
The American Cancer Society acknowledges that it receives support from the Coca-Cola Company for its Choose You campaign. This is a campaign to promote healthy living, including eating right and maintaining good nutrition.
The American Cancer Society was bought off into endorsing as a corporate partner a company that opposes improving school nutrition standards and opposes measures to limit infants' exposure to bisphenol-A, a possible carcinogen to which the ACS publicly states people should limit their exposure. What a fine choice for a partner!
To make matters even worse, the American Cancer Society misleads the public by stating that it will not partner with any company whose products contribute to obesity. Clearly, it is violating its own stated criteria here. The ACS claims: "If a product contributes to obesity, a major contributor of cancer, it's out." So much for honesty.
While the ACS might try to argue that it is really just Diet Coke and Sprite Zero which are sponsoring the Choose You campaign, that is hogwash. There is no such company as Diet Coke or Sprite Zero and the corporate sponsor is the Coca-Cola Company, not Diet Coke or Sprite Zero. The Coca-Cola Company does indeed produce products that contribute to obesity, so the American Cancer Society's claim is a bunch of baloney.
I'll have to remember this trick. The next time I need money for my anti-smoking research, I'll ask Philip Morris. But I'll publicize the sponsorship of my research as coming from Chateau Ste. Michelle wine (another product of Altria, in addition to Marlboro cigarettes). I can then declare on my web site: "I refuse to accept any sponsorship of my research from any product which contributes to tobacco-related disease." That way, I can have my cake and eat it too. I can claim to be following science-based, ethical standards.
That the American Cancer Society is relying on such flimsy and totally bogus reasoning to defend this sponsorship is actually worse than the sponsorship itself. Why? Because the organization is essentially lying to the public. It's a huge hoax that they are pulling on their own constituents, volunteers, and donors. Frankly, it's sickening to see how low the ACS has sunk with this cheap ploy.
2. The National Heart, Blood, and Lung Institute
Apparently in return for its donation to the Foundation for the National Institutes of Health, the NHLBI agreed to allow Coca-Cola to be a partner in its Heart Truth campaign. By allowing Coca-Cola to be a partner, the NHLBI has allowed Coca-Cola to boast on its web site that: "Our research with consumers has told us that women today are increasingly mindful of making choices that positively impact their lives. For them, drinking Diet Coke is an essential part of their modern pursuit of well-being." OK then. I didn't realize that the NHLBI was in the business of marketing Diet Coke.
In its press release, Coca-Cola boasts that "consumers can find more information on the Diet Coke's Red Dress Program at www.mycokerewards.com." Actually, the first thing I noticed at that site was a fast food advertisement for Wendy's. What the site is actually promoting - rather than reducing heart disease and improving nutrition - is Wendy's new natural-cut fries.
But these natural-cut fries are actually just as unhealthy as the old ones. In fact, they deliver 10 more calories, delivering a whopping 420 calories, 20 grams of fat, 500 milligrams of sodium, and 54 grams of carbohydrates. These all make it less healthy than the original fries.
Whether it likes it or not, through its partnership with Coca-Cola, the NHLBI is actually helping to promote and market Wendy's new natural-cut fries at 420 calories and a half gram of sodium per serving. What kind of contribution is that going to make to the NHLBI's goal of reducing hypertension, obesity, and heart disease?
And don't give me the same argument that it is actually Diet Coke, and not Coca-Cola, that is sponsorship the campaign. Diet Coke is not a company, and the NHLBI knows full well that it is the Coca-Cola Company which is sponsoring the campaign and getting a huge marketing opportunity from it - not only for Diet Coke but for its entire line of products, including Coke itself, which is prominently displayed in an advertisement on the web site that was touted as providing information on the Little Red Dress program.
So now we have even more to the rest of the story. The company which the American Dietetic Association and American Academy of Pediatrics tout as being a leader in the national movement to curb childhood obesity is actively promoting fast food - specifically, french fries.
Does the NHLBI really want to be marketing french fries to the public? Through its partnership with Coca-Cola, it is unfortunately also partnering in this marketing of french fries. Unfortunately, there's no such thing as partnering with just "Diet Coke." If you partner with Coca-Cola, you get the whole shebang. And that includes the promotion of 420 calorie per serving french fries.
And, might I add, that's only a side dish. You're getting 420 calories and half a gram of salt from a side dish alone. The most basic item at Wendy's - it's 1/4 pound burger - delivers 550 calories, 28 grams of fat, and 1.28 grams of sodium. Yes, you read that right - 1.28 grams of sodium.
I do think it's time for the American Cancer Society and the NHLBI to re-examine their criteria for corporate partnerships.
As if this all isn't enough, it gets much worse. Apparently, the NHLBI has agreed to have its red dress logo placed on Diet Coke cans, thus resulting in the Institute's endorsement of Diet Coke, even though diet sodas have been linked to obesity.
Not only is the NHLBI helping to market french fries, but it is directly helping to market soda.
Frankly, I don't think that Coca-Cola really needs this help in marketing its products from the NHLBI and American Cancer Society. The company seems to be doing pretty well on its own, selling 1.4 billion servings of its beverages each day.
Now all we need is a federal agency or cancer organization that will actually help fight obesity, heart disease, and cancer, rather than help promote and market products that contribute to these problems.
SOURCE: Most of the information upon which this post is based comes from the following source -- Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006
You are a non-profit organization that is involved in lobbying all 50 state legislatures. You do not produce or market any products so you are not making any direct contribution to the nation's obesity problems. However, your lobbying efforts are directed against legislation to improve school nutrition standards, limit the availability of soda and junk food in schools, and reduce the consumption of junk food and soda.
You approach the National Heart, Lung, and Blood Institute (NHLBI) - nation's leading federal agency fighting heart disease (and therefore obesity) - and ask if you can be recognized by this federal agency as a partner in the national effort to reduce heart disease. You also approach the American Cancer Society with the same request.
Then, you go for broke. You ask the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to also endorse you as a full-fledged partner in the national effort to reduce childhood obesity.
When these organizations question you about your activities, you are honest and reveal that you actively lobby against legislation in all 50 states to improve school nutrition standards, limit the availability of soda and junk food in schools, and reduce the consumption of junk food and soda. You acknowledge that you are even lobbying against basic environmental health policies like bottle bills, which are supported by even the most conservative groups.
You also acknowledge that when advocates in one state attempted to set nutrition guidelines on food and beverages, you hired a lobbying firm to gut the law. "The political struggle included an eight-hour House debate in which lawmakers engaged in stall tactics and delayed the process by adding unrelated amendments. [Your] lobbyists also shared data regarding school income from soda sales with lawmakers behind closed doors so that nutrition advocates could not refute the information. [You] also delivered a well-stocked cooler [of Coca-Cola] to the Democratic caucus room just before the House was expected to vote on the bill." (Source: Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006)
In 2010 alone, you spent $4.9 million dollars lobbying against public health legislation, of which nearly a half million went to seven private lobbying firms. You also donated money to a front group which runs attack campaigns against public health and nutrition groups. The front group that you fund is run by an organization that also funds efforts to prevent stricter drunk driving legislation.
Do you think you would have a prayer in hell of ever getting the National Heart, Lung, and Blood Institute, the American Cancer Society, the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to endorse you as a full-fledged partner in the effort to fight childhood obesity and improve the public's health?
Probably not, but that isn't the actual scenario in question.
The actual scenario is as follows:
Everything above is true, including:
- your lobbying against legislation in all 50 states to improve school nutrition standards, limit the availability of soda and junk food in schools, and reduce the consumption of junk food and soda; your lobbying against basic environmental health policies like bottle bills, which are supported by even the most conservative groups;
- your hiring a law firm to gut a state bill to improve school nutrition standards;
- your delivering a cooler of Coca-Cola to the Democratic caucus room just before the vote;
- your spending $4.9 million dollars lobbying against public health legislation, of which nearly a half million went to seven private lobbying firms; and
- your donating money to a front group which runs attack campaigns against public health and nutrition groups and which is funded by an organization that also funds efforts to prevent stricter drunk driving legislation.
Now, if you didn't think you would have a prayer in hell of ever getting the National Heart, Lung, and Blood Institute, the American Cancer Society, the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to endorse you as a full-fledged partner in the effort to fight childhood obesity and improve the public's health before, what kind of chances do you think you'd have now?
On top of all your lobbying against policies to improve school nutrition and reduce junk food and soda consumption, on top of your millions of dollars of lobbying expenditures to fight public health and environmental health policies, and on top of your donations to an organization that is tied to even the most sensible policies like strict drunk driving laws, you are the leading producer of the actual soda that is contributing significantly to the obesity problem.
The Rest of the Story
The rest of the story is that this scenario actually occurred (see Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006), and that the corporation involved - the Coca-Cola Company - was successful in buying off the endorsements of the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians, as I detailed last week. In addition, as I reveal today, this corporation was successful in gaining similar endorsements and partnerships from the federal government - the National Heart, Lung, and Blood Institute (NHLBI) - and a health charity group: the American Cancer Society. Sadly, these organizations were also bought off by monetary donations, allowing Coca-Cola to achieve the unimaginable feat of opposing even basic school nutrition standards by being recognized by the NHLBI and the American Cancer Society as being a leader in the movement to reduce heart disease by controlling obesity.
1. The American Cancer Society
The American Cancer Society acknowledges that it receives support from the Coca-Cola Company for its Choose You campaign. This is a campaign to promote healthy living, including eating right and maintaining good nutrition.
The American Cancer Society was bought off into endorsing as a corporate partner a company that opposes improving school nutrition standards and opposes measures to limit infants' exposure to bisphenol-A, a possible carcinogen to which the ACS publicly states people should limit their exposure. What a fine choice for a partner!
To make matters even worse, the American Cancer Society misleads the public by stating that it will not partner with any company whose products contribute to obesity. Clearly, it is violating its own stated criteria here. The ACS claims: "If a product contributes to obesity, a major contributor of cancer, it's out." So much for honesty.
While the ACS might try to argue that it is really just Diet Coke and Sprite Zero which are sponsoring the Choose You campaign, that is hogwash. There is no such company as Diet Coke or Sprite Zero and the corporate sponsor is the Coca-Cola Company, not Diet Coke or Sprite Zero. The Coca-Cola Company does indeed produce products that contribute to obesity, so the American Cancer Society's claim is a bunch of baloney.
I'll have to remember this trick. The next time I need money for my anti-smoking research, I'll ask Philip Morris. But I'll publicize the sponsorship of my research as coming from Chateau Ste. Michelle wine (another product of Altria, in addition to Marlboro cigarettes). I can then declare on my web site: "I refuse to accept any sponsorship of my research from any product which contributes to tobacco-related disease." That way, I can have my cake and eat it too. I can claim to be following science-based, ethical standards.
That the American Cancer Society is relying on such flimsy and totally bogus reasoning to defend this sponsorship is actually worse than the sponsorship itself. Why? Because the organization is essentially lying to the public. It's a huge hoax that they are pulling on their own constituents, volunteers, and donors. Frankly, it's sickening to see how low the ACS has sunk with this cheap ploy.
2. The National Heart, Blood, and Lung Institute
Apparently in return for its donation to the Foundation for the National Institutes of Health, the NHLBI agreed to allow Coca-Cola to be a partner in its Heart Truth campaign. By allowing Coca-Cola to be a partner, the NHLBI has allowed Coca-Cola to boast on its web site that: "Our research with consumers has told us that women today are increasingly mindful of making choices that positively impact their lives. For them, drinking Diet Coke is an essential part of their modern pursuit of well-being." OK then. I didn't realize that the NHLBI was in the business of marketing Diet Coke.
In its press release, Coca-Cola boasts that "consumers can find more information on the Diet Coke's Red Dress Program at www.mycokerewards.com." Actually, the first thing I noticed at that site was a fast food advertisement for Wendy's. What the site is actually promoting - rather than reducing heart disease and improving nutrition - is Wendy's new natural-cut fries.
But these natural-cut fries are actually just as unhealthy as the old ones. In fact, they deliver 10 more calories, delivering a whopping 420 calories, 20 grams of fat, 500 milligrams of sodium, and 54 grams of carbohydrates. These all make it less healthy than the original fries.
Whether it likes it or not, through its partnership with Coca-Cola, the NHLBI is actually helping to promote and market Wendy's new natural-cut fries at 420 calories and a half gram of sodium per serving. What kind of contribution is that going to make to the NHLBI's goal of reducing hypertension, obesity, and heart disease?
And don't give me the same argument that it is actually Diet Coke, and not Coca-Cola, that is sponsorship the campaign. Diet Coke is not a company, and the NHLBI knows full well that it is the Coca-Cola Company which is sponsoring the campaign and getting a huge marketing opportunity from it - not only for Diet Coke but for its entire line of products, including Coke itself, which is prominently displayed in an advertisement on the web site that was touted as providing information on the Little Red Dress program.
So now we have even more to the rest of the story. The company which the American Dietetic Association and American Academy of Pediatrics tout as being a leader in the national movement to curb childhood obesity is actively promoting fast food - specifically, french fries.
Does the NHLBI really want to be marketing french fries to the public? Through its partnership with Coca-Cola, it is unfortunately also partnering in this marketing of french fries. Unfortunately, there's no such thing as partnering with just "Diet Coke." If you partner with Coca-Cola, you get the whole shebang. And that includes the promotion of 420 calorie per serving french fries.
And, might I add, that's only a side dish. You're getting 420 calories and half a gram of salt from a side dish alone. The most basic item at Wendy's - it's 1/4 pound burger - delivers 550 calories, 28 grams of fat, and 1.28 grams of sodium. Yes, you read that right - 1.28 grams of sodium.
I do think it's time for the American Cancer Society and the NHLBI to re-examine their criteria for corporate partnerships.
As if this all isn't enough, it gets much worse. Apparently, the NHLBI has agreed to have its red dress logo placed on Diet Coke cans, thus resulting in the Institute's endorsement of Diet Coke, even though diet sodas have been linked to obesity.
Not only is the NHLBI helping to market french fries, but it is directly helping to market soda.
Frankly, I don't think that Coca-Cola really needs this help in marketing its products from the NHLBI and American Cancer Society. The company seems to be doing pretty well on its own, selling 1.4 billion servings of its beverages each day.
Now all we need is a federal agency or cancer organization that will actually help fight obesity, heart disease, and cancer, rather than help promote and market products that contribute to these problems.
SOURCE: Most of the information upon which this post is based comes from the following source -- Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006
Friday, April 15, 2011
The Two Biggest Reasons Why the ADA, AAP, and AAFP Should Not Take Money from Coca-Cola and Other Big Food Companies
I have written extensively this week on the corporate partnerships that three public health organizations - the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Dietetic Association - have forged with Coca-Cola and other Big Food companies and how these partnerships aid the marketing plans and marketing efforts of these companies, undermine the integrity and public health mission of these supposedly public health-committed organizations, and directly undermine the public's health itself by helping to market unhealthy products.
Although I have been the target of many personal attacks due to my coming out publicly with these opinions, it is clear to me that I have struck a nerve somewhere and that the defensive reaction is due to an underlying realization that these corporate partnerships are not sustainable if these organizations are to retain any semblance of integrity.
I want to close the week by putting forward two pieces of evidence that demonstrate why these partnerships are unacceptable.
1. Coca-Cola and other Big Food companies are using these partnerships to enhance their corporate image, and therefore, their bottom line: sales of unhealthy products that are contributing towards the nation's obesity epidemic.
In its 2010 annual report, Coca-Cola writes: "Obesity and other health concerns may reduce demand for some of our products. Consumers, public health officials and government officials are becoming increasingly concerned about the public health consequences associated with obesity, particularly among young people. In addition, some researchers, health advocates and dietary guidelines are encouraging consumers to reduce consumption of sugar-sweetened beverages, including those sweetened with HFCS or other nutritive sweeteners. Increasing public concern about these issues; possible new taxes and governmental regulations concerning the marketing, labeling or availability of our beverages; and negative publicity resulting from actual or threatened legal actions against us or other companies in our industry relating to the marketing, labeling or sale of sugar-sweetened beverages may reduce demand for our beverages, which could affect our profitability."
Thus, Coca-Cola directly acknowledges that a negative public image impacts its bottom line - profits - and therefore, that improving its public image will do the opposite: increase Coke sales.
In its 2010 Sustainability Report, Coca-Cola makes it clear that it is using the ADA, AAP, and AAFP to improve its public image by reaching millions of consumers. It boasts about how responsible a company it is due to its partnership with these organizations: "In the United States, we currently reach millions of consumers annually through our work with the American Dietetic Association; the National Heart, Lung, and Blood Institute’s The Heart Truth® campaign; the American Cancer Society’s Choose You™ campaign; the American College of Sports Medicine; the Preventive Cardiovascular Nurses Association; and the American Academy of Family Physicians."
Pepsico, in its 2010 annual report, also makes clear the connection between the company's public image and its bottom line: "Damage to our reputation or loss of consumer confidence in our products for any of these or other reasons could result in decreased demand for our products and could have a material adverse effect on our business, financial condition and results of operations, as well as require additional resources to rebuild our reputation."
2. The American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians are supporting companies that oppose virtually every state-specific public health policy related to improvement of school nutrition, reduction of junk food and soda consumption, and environmental health and safety.
Regardless of its public statements, Coca-Cola is clearly opposed to virtually all state legislation proposed by public health groups to improve school nutrition and reduce the consumption of unhealthy, sugar-sweetened beverages.
Through its contributions to the Grocers Manufacturers Association (GMA), Coca-Cola is opposing any and all taxes on sugar-sweetened beverages (soft drinks), opposing the removal of BPA from bottles containing liquids consumed by infants, opposing legislation to simply require the disclosure of product ingredients, opposing taxes on candy, opposing bottle bills, opposing all restrictions on BPA-containing packaging, opposing standards for food processing, and opposing school nutrition standards.
To be clear: "GMA submitted testimony in opposition to mandated school nutrition standards."
That the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians can claim that Coca-Cola is committed to improving childhood health in the face of this company's opposition to even the most basic school nutrition standards is, in my opinion, despicable.
And whether they like it or not, through their support of Coca-Cola, the ADA, AAP, and AAFP are supporting a company that opposes school nutrition standards. Moreover, by supporting Coca-Cola, they are shooting themselves in the foot because whether they like it or not, their corporate partnerships are actually working to: oppose any and all taxes on sugar-sweetened beverages (soft drinks), oppose the removal of BPA from bottles containing liquids consumed by infants, oppose legislation to simply require the disclosure of product ingredients, oppose taxes on candy, oppose bottle bills, oppose all restrictions on BPA-containing packaging, oppose standards for food processing, and oppose school nutrition standards.
Despite the public statements of Coca-Cola about how it is committed to improving school nutrition, when it really comes down to it, the company is opposed to every reasonable measure - even the most basic school nutrition standards. Just like the tobacco companies used to do, Coca-Cola is talking out of one side of its mouth, and out of the other, it is working behind the scenes to oppose the very measures that it purports to support.
That the AAP, AAFP, and ADA have fallen for Coca-Cola's tricks is one possibility. The other, which I find more likely, is that they have been bought off. In other words, that the receipt of large amounts of money has caused them to look the other way. It's amazing what a little financial support will do. And of course, this is precisely the reason why companies like Coca-Cola and Pepsico include the sponsorship of public health organizations in their marketing plans.
Although I have been the target of many personal attacks due to my coming out publicly with these opinions, it is clear to me that I have struck a nerve somewhere and that the defensive reaction is due to an underlying realization that these corporate partnerships are not sustainable if these organizations are to retain any semblance of integrity.
I want to close the week by putting forward two pieces of evidence that demonstrate why these partnerships are unacceptable.
1. Coca-Cola and other Big Food companies are using these partnerships to enhance their corporate image, and therefore, their bottom line: sales of unhealthy products that are contributing towards the nation's obesity epidemic.
In its 2010 annual report, Coca-Cola writes: "Obesity and other health concerns may reduce demand for some of our products. Consumers, public health officials and government officials are becoming increasingly concerned about the public health consequences associated with obesity, particularly among young people. In addition, some researchers, health advocates and dietary guidelines are encouraging consumers to reduce consumption of sugar-sweetened beverages, including those sweetened with HFCS or other nutritive sweeteners. Increasing public concern about these issues; possible new taxes and governmental regulations concerning the marketing, labeling or availability of our beverages; and negative publicity resulting from actual or threatened legal actions against us or other companies in our industry relating to the marketing, labeling or sale of sugar-sweetened beverages may reduce demand for our beverages, which could affect our profitability."
Thus, Coca-Cola directly acknowledges that a negative public image impacts its bottom line - profits - and therefore, that improving its public image will do the opposite: increase Coke sales.
In its 2010 Sustainability Report, Coca-Cola makes it clear that it is using the ADA, AAP, and AAFP to improve its public image by reaching millions of consumers. It boasts about how responsible a company it is due to its partnership with these organizations: "In the United States, we currently reach millions of consumers annually through our work with the American Dietetic Association; the National Heart, Lung, and Blood Institute’s The Heart Truth® campaign; the American Cancer Society’s Choose You™ campaign; the American College of Sports Medicine; the Preventive Cardiovascular Nurses Association; and the American Academy of Family Physicians."
Pepsico, in its 2010 annual report, also makes clear the connection between the company's public image and its bottom line: "Damage to our reputation or loss of consumer confidence in our products for any of these or other reasons could result in decreased demand for our products and could have a material adverse effect on our business, financial condition and results of operations, as well as require additional resources to rebuild our reputation."
2. The American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians are supporting companies that oppose virtually every state-specific public health policy related to improvement of school nutrition, reduction of junk food and soda consumption, and environmental health and safety.
Regardless of its public statements, Coca-Cola is clearly opposed to virtually all state legislation proposed by public health groups to improve school nutrition and reduce the consumption of unhealthy, sugar-sweetened beverages.
Through its contributions to the Grocers Manufacturers Association (GMA), Coca-Cola is opposing any and all taxes on sugar-sweetened beverages (soft drinks), opposing the removal of BPA from bottles containing liquids consumed by infants, opposing legislation to simply require the disclosure of product ingredients, opposing taxes on candy, opposing bottle bills, opposing all restrictions on BPA-containing packaging, opposing standards for food processing, and opposing school nutrition standards.
To be clear: "GMA submitted testimony in opposition to mandated school nutrition standards."
That the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians can claim that Coca-Cola is committed to improving childhood health in the face of this company's opposition to even the most basic school nutrition standards is, in my opinion, despicable.
And whether they like it or not, through their support of Coca-Cola, the ADA, AAP, and AAFP are supporting a company that opposes school nutrition standards. Moreover, by supporting Coca-Cola, they are shooting themselves in the foot because whether they like it or not, their corporate partnerships are actually working to: oppose any and all taxes on sugar-sweetened beverages (soft drinks), oppose the removal of BPA from bottles containing liquids consumed by infants, oppose legislation to simply require the disclosure of product ingredients, oppose taxes on candy, oppose bottle bills, oppose all restrictions on BPA-containing packaging, oppose standards for food processing, and oppose school nutrition standards.
Despite the public statements of Coca-Cola about how it is committed to improving school nutrition, when it really comes down to it, the company is opposed to every reasonable measure - even the most basic school nutrition standards. Just like the tobacco companies used to do, Coca-Cola is talking out of one side of its mouth, and out of the other, it is working behind the scenes to oppose the very measures that it purports to support.
That the AAP, AAFP, and ADA have fallen for Coca-Cola's tricks is one possibility. The other, which I find more likely, is that they have been bought off. In other words, that the receipt of large amounts of money has caused them to look the other way. It's amazing what a little financial support will do. And of course, this is precisely the reason why companies like Coca-Cola and Pepsico include the sponsorship of public health organizations in their marketing plans.
Thursday, April 14, 2011
Some American Dietetic Association Members Defend ADA's Acceptance of Coke and Pepsi Money; Cite Healthy Products Made by These Companies
While I received many responses from American Dietetic Association (ADA) members who shared their personal opinion that the ADA should discontinue its sponsorship by the Coca-Cola Company and Pepsico, a few members defended these sponsorships. Their main argument was that although these companies market unhealthy products like Coke and Pepsi that are contributing to the obesity epidemic, they also market healthy products.
One ADA member wrote: "the companies you criticize have a wide variety of products available from good for you to more indulgent. These companies employ many of the best scientists in the world because they want to make a difference in providing healthier options to consumers."
Another wrote: "Both Coca Cola and Pepsi are massive companies that represent a multitude of brands. According to Cokes own website they have 3500 different brands in over 200 countries including water, fruit juice and soy beverages. Pepsi's brands include Frito Lay, Tropicana, and Quaker. Everyone focuses on the "worst" of these brands, the high calorie sodas, but seems to ignore all of the other possibilities within both Pepsi and Coke."
The Rest of the Story
One could make the exact same argument about Big Tobacco. But can you imagine if an anti-smoking group which accepted money from tobacco companies had defended these sponsorships by arguing that although Altria (maker of Marlboro, Virginia Slims, Basic, and Merit) markets Marlboro cigarettes, it also produced Balance Bars, Boca Burgers, Grape Nuts cereal, Shredded Wheat, and Light n' Lively yogurt. Sure Altria markets deadly cigarettes, but it also marketed healthy products such as nutritious cereals and yogurt and even vegetable burgers - a very healthy alternative to beef burgers.
Can you imagine the Campaign for Tobacco-Free Kids ever defending corporate funding from R.J. Reynolds (when it owned Nabisco) by arguing that although R.J. Reynolds makes Camel cigarettes, they also market very healthy snacks, including Wheat Thins, Stoned Wheat Thins, and Wheatsworth crackers?
When Coca-Cola drops its marketing of Coke and only sells its healthy line of products, then you can talk to me about how Coca-Cola is promoting the public's health.
When Coca-Cola stops lobbying against policies to improve school nutrition, then you can talk to me about how this corporation is promoting health.
The truth is, Coca-Cola and Pepsico are working directly against our public health goals. They are lobbying vigorously against even the most basic policies to improve school-based nutrition, policies that are supported by virtually every public health organization.
By supporting Coke and Pepsi's marketing plans, the ADA is literally shooting itself in the foot. It is supporting companies that are lobbying against improved school nutrition. It is partnering with an enemy of improved nutrition for school children.
That bears repeating. The ADA is partnering with an enemy of improved nutrition for school children.
As Michele Simon pointed out, Coca-Cola and Pepsico are "on record as opposing virtually every state bill across the nation that would restrict the sale of junk food or soda in schools."
What great companies for the ADA to be partnering with.
But I guess that's OK, because Coca-Cola also sells Gold Peak green tea and Pepsico also sells Tropicana orange juice.
One ADA member wrote: "the companies you criticize have a wide variety of products available from good for you to more indulgent. These companies employ many of the best scientists in the world because they want to make a difference in providing healthier options to consumers."
Another wrote: "Both Coca Cola and Pepsi are massive companies that represent a multitude of brands. According to Cokes own website they have 3500 different brands in over 200 countries including water, fruit juice and soy beverages. Pepsi's brands include Frito Lay, Tropicana, and Quaker. Everyone focuses on the "worst" of these brands, the high calorie sodas, but seems to ignore all of the other possibilities within both Pepsi and Coke."
The Rest of the Story
One could make the exact same argument about Big Tobacco. But can you imagine if an anti-smoking group which accepted money from tobacco companies had defended these sponsorships by arguing that although Altria (maker of Marlboro, Virginia Slims, Basic, and Merit) markets Marlboro cigarettes, it also produced Balance Bars, Boca Burgers, Grape Nuts cereal, Shredded Wheat, and Light n' Lively yogurt. Sure Altria markets deadly cigarettes, but it also marketed healthy products such as nutritious cereals and yogurt and even vegetable burgers - a very healthy alternative to beef burgers.
Can you imagine the Campaign for Tobacco-Free Kids ever defending corporate funding from R.J. Reynolds (when it owned Nabisco) by arguing that although R.J. Reynolds makes Camel cigarettes, they also market very healthy snacks, including Wheat Thins, Stoned Wheat Thins, and Wheatsworth crackers?
When Coca-Cola drops its marketing of Coke and only sells its healthy line of products, then you can talk to me about how Coca-Cola is promoting the public's health.
When Coca-Cola stops lobbying against policies to improve school nutrition, then you can talk to me about how this corporation is promoting health.
The truth is, Coca-Cola and Pepsico are working directly against our public health goals. They are lobbying vigorously against even the most basic policies to improve school-based nutrition, policies that are supported by virtually every public health organization.
By supporting Coke and Pepsi's marketing plans, the ADA is literally shooting itself in the foot. It is supporting companies that are lobbying against improved school nutrition. It is partnering with an enemy of improved nutrition for school children.
That bears repeating. The ADA is partnering with an enemy of improved nutrition for school children.
As Michele Simon pointed out, Coca-Cola and Pepsico are "on record as opposing virtually every state bill across the nation that would restrict the sale of junk food or soda in schools."
What great companies for the ADA to be partnering with.
But I guess that's OK, because Coca-Cola also sells Gold Peak green tea and Pepsico also sells Tropicana orange juice.
Wednesday, April 13, 2011
American Academy of Pediatrics and American Academy of Family Physicians Prostitute Their Integrity by Accepting Sugar-Laden Soft Drink Money
Doctors are Helping to Market Soda to America's Children
The American Academy of Family Physicians (AAFP) has entered into a corporate partnership with the Coca-Cola Company, in which Coca-Cola is providing money to AAFP in return for public recognition, improvement of its public image, distraction of public attention away from the role of Coca-Cola's products in the obesity epidemic, a lucrative marketing opportunity for Coke, and ultimately, an increase in its bottom line (Coke sales).
The large expenditure on the part of Coca-Cola is very well spent, and should be applauded vigorously by Coca-Cola stockholders. The corporation is already starting to reap the benefits of this rare marketing opportunity.
On the web site that is apparently being supported by Coca-Cola, the AAFP actually goes so far as cautioning people not to necessarily limit their consumption of soda: "Sugar-sweetened drinks, such as fruit juice, fruit drinks, regular soft drinks, sports drinks, energy drinks, sweetened or flavored milk and sweetened iced tea can add lots of sugar and calories to your diet. But staying hydrated is important for good health."
This sounds like a statement coming right out of the mouth of Coca-Cola itself. The company repeatedly refers to its sugar-laden soft drinks as a way of meeting your "hydration needs."
It's quite interesting that the AAFP does not say: "Sugar-sweetened drinks, such as fruit juice, fruit drinks, regular soft drinks, sports drinks, energy drinks, sweetened or flavored milk and sweetened iced tea can add lots of sugar and calories to your diet. To stay well-hydrated, make sure to drink plenty of water, as water keeps you hydrated without adding extra calories."
Whatever Coca-Cola paid for achieving the actual statement made by the AAFP instead of the alternative statement that is actually the appropriate public health statement was well worth the expenditure. To get the nation's body of family physicians to caution people against limiting their soda intake is more than money could ever be expected to buy. The Coca-Cola executives who made this deal with AAFP must be laughing in their accomplishments.
Coca-Cola does not deserve all the credit here. The AAFP also accepts marketing expenditures (i.e., corporate sponsorship money) from Pepsico as well. Coca-Cola is listed as a Grand Patron, while Pepsico contributes at the "Sustaining" level.
The American Academy of Family Physicians is not the only physician group that has prostituted itself and sold out its values and integrity by lending its good name to the marketing efforts of Coca-Cola.
In 2010, the president of the American Academy of Pediatrics (AAP) helped Coca-Cola market its products by participating in Coke's sponsorship of the 2010 Olympic Torch relay. Not to be outdone, she was joined by a member of the American Academy of Family Physicians and the president of the American Dietetic Association. These health professionals stood shoulder-to-shoulder with top Coca-Cola sales and marketing executives in this major effort to promote Coke internationally.
Do you think it is any coincidence that Coca-Cola found a way to choose prominent representatives from the AAP, AAFP, and ADA? Of course not. The obvious purpose of this marketing ploy was to associate the good name of these organizations with Coke and to help deter potential role of these organizations in calling for policies that would hurt Coke sales. This is sheer marketing brilliance!
More impressively and reeking with irony, the American Academy of Pediatrics accepted funding from Coca-Cola to sponsor its "Healthy Children" web site. On that site, the AAP states that the Coca-Cola Company is committed: "to better the health of children worldwide."
Whatever Coca-Cola contributed to the American Academy of Pediatrics to garner that statement and recognition as a leader in the child health movement internationally was nowhere near enough. This is blatant prostitution, where the AAP is essentially selling its site to the highest bidder. Do you want to be recognized as a leader in children's health internationally? Simply pay off the AAP. Never mind the fact that you market a product which is a major contributor toward childhood obesity.
And never mind the fact that it was alleged that your company was selling products with high levels of pesticides to rural villagers in India. According to Source Watch: "In August 2003, the Centre for Science and Environment had announced that a dozen drinks, produced by both Coca-Cola and Pepsi, contained unacceptably high levels of pesticides. However, if the formation of the advisory committee was designed to deflect attention, it was of little help when two days after its first meeting the Kerala high court ordered the company to stop extracting groundwater for its bottling plant near Plachimada village. The ruling followed a 608 day long protest by local villagers who complained the water extraction by Coca-Cola was so great it was drying their rice paddies out and killing their coconut palms."
Moreover, the very company that the AAP describes as an international leader in children's health lobbied vigorously against legislation that would have improved school nutrition in Connecticut.
According to Source Watch: "Connecticut Governor Jodi Rell vetoed what would have been the nation's strongest school-based nutrition law in June 2005, a bill that would have allowed only water, juice, and milk to be sold during the school day, K-12. In 2004, advocates had attempted to set nutrition guidelines on food and beverages, but lobbying by Coke and PepsiCo gutted the law. Coke hired Patrick Sullivan of Sullivan & LeShane to lobby on its behalf. The political struggle included an eight-hour House debate in which lawmakers engaged in stall tactics and delayed the process by adding unrelated amendments. Coke lobbyists also shared data regarding school income from soda sales with lawmakers behind closed doors so that nutrition advocates could not refute the information. Coke also delivered a well-stocked cooler to the Democratic caucus room just before the House was expected to vote on the bill."
And this is the company that the AAP tells us is an international leader in the protection of children's health. These physicians should be completely ashamed of themselves.
Rosenberg and I explained, in a 2009 article in Tobacco Control, how corporate sponsorship plays a critical role in marketing by enhancing the public image of the company, which enhances its bottom line -- product sales: "Through its corporate sponsorship, a ... company may be able to create good will among the public ... it may help put a “human” face on the corporation and point out its contributions to the community, taking the focus away from damage caused by its products." In turn, this helps the company stave off policy changes that would improve the public's health by reducing the sale of its unhealthy products.
By accepting these sponsorships from the leading manufacturers of sugar-laden soft drinks that are contributing to the nation's obesity epidemic, by playing a role in the marketing of these products, and by actively promoting these companies as international leaders in children's health, the American Academy of Family Physicians and American Academy of Pediatrics are butchering the Hippocratic Oath that all of its physician members took. Rather than "doing no harm," these sponsorships are doing tremendous harm to the protection of the public's health by helping these massive corporations market their unhealthy products.
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