A year ago, when the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) began considering whether to recommend that the FDA ban menthol cigarettes, the FDA knew it had two basic choices:
1) To ban menthol cigarettes; and
2) Not to ban menthol cigarettes.
Now, after a year of time and the expenditure of a huge amount of money (taxpayer money, I might add), after substantial research and analysis, and after meeting after meeting evaluating the policy and scientific issues, the TPSAC final report does little other than to essentially tell the FDA that it has two basic choices:
1) To ban menthol cigarettes; and
2) Not to ban menthol cigarettes.
The report makes no recommendation and doesn't even offer a hint as to which of the two options would be better. It does not put forward a recommendation for either option #1 or option #2. Essentially, the entire report concludes by telling the FDA that it has these two options. But no recommendation is made in terms of which option the FDA should take.
Sorry to break the news to you, but the FDA knew it had these two options a year ago. What the Agency needed was an expert evaluation of the policy and scientific issues, leading to a recommendation of which of the two options it should take.
Can you imagine a similar "recommendation" coming out of an FDA advisory committee charged with evaluating whether the FDA should approve a new drug? Can you imagine such a committee coming out with the following recommendation:
"We recommend that the FDA consider whether to approve this new drug or not."
Thanks, but with advice like that we'd be better off saving the money and simply letting the FDA deliberate the issue itself from the beginning.
The TPSAC simply punted here, making no recommendation and simply pushing the issue back to the Agency. The FDA could not possibly have received anything less helpful than this advice: "You need to study the issue and decide what to do."
Gee, thank you. That really help clarify the situation for us.
The Rest of the Story
Both the conclusions and "recommendations" of the TPSAC report are no-brainers that were readily apparent one year ago without any expenditure of money on research or analysis. Let's break them down one by one and you'll see what I mean:
Conclusion #1: "Menthol cigarettes have an adverse impact on public health in the United States."
Of course menthol cigarettes have an adverse impact on public health in the United States. All cigarettes have an adverse impact on public health in the United States. Had TPSAC concluded that menthol cigarettes do not have an adverse impact on public health in the United States, I would have recommended that the panelists undergo a psychiatric examination. This conclusion is obvious and it didn't take a year of study to derive. We knew this a year ago. It's hard to believe that all of the Committee's research, analysis, and evaluation resulted in this obvious, self-evident conclusion. The taxpayers wasted their money if this was all they got out of the Committee's deliberations.
Conclusion #2: There are no public health benefits of menthol compared to non-menthol cigarettes."
Of course there are no public health benefits of menthol compared to non-menthol cigarettes. We already knew that. Not even the tobacco companies were alleging that menthol cigarettes provide some public health benefit. Once again, if the Committee had concluded that menthol cigarettes provide a public health benefit compared to non-menthol cigarettes, I would have recommended a psychiatric examination for the panelists before they returned home from Washington. Once again, it's hard to believe that all of the Committee's research, analysis, and evaluation resulted in this obvious, self-evident conclusion. The taxpayers wasted their money if this was all they got out of the Committee's deliberations.
"Recommendation" #1: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States."
Apparently, TPSAC does not understand the difference between a recommendation and a conclusion. This is why I put the word "recommendation" in quotation marks.
TPSAC's basic "recommendation" is not a recommendation at all. It is, in fact, a conclusion. By definition, a recommendation is a suggestion or piece of advice. The TPSAC's basic "recommendation" is not a recommendation at all because it doesn't do either. It is a conclusion, devoid of any suggestion or advice.
Stating that the removal of menthol cigarettes would benefit public health doesn't suggest any particular action to the FDA. A recommendation would have looked something like this:
"We recommend that the FDA ban menthol cigarettes."
Or this:
"We recommend that the FDA not ban menthol cigarettes."
Moreover, even as a conclusion, the statement is self-evident and obvious. Of course banning menthol cigarettes would have a public health benefit. We knew this a year ago. If it didn't have a public health benefit, then why was Lorillard so worried about such a potential decision? Was there ever a doubt that in the face of a ban on menthol cigarettes, some smokers would choose to quit smoking? Of course not. Lorillard certainly knew that. I knew that. And I think the FDA knew that.
In fact, it is specifically because Congress knew that a menthol ban was the one potential policy it might include in the Tobacco Act that would substantially benefit the public's health (a.k.a., decrease tobacco sales) that our politicians chose to exempt menthol in the first place.
We really didn't need a year of research and taxpayer expenditures to tell us what Lorillard told us over a year ago: Of course banning menthol will have a public health benefit. It will decrease cigarette sales because it will lead some smokers to quit. Not all smokers, of course, But some smokers. And it might deter some youth from smoking as well. Not all youth, but some youth. This conclusion was obvious from the start and in fact, it is because of a fear that a menthol ban would actually impact tobacco sales that the health groups (i.e., the Campaign for Tobacco-Free Kids and Friends) did not include such a ban in the legislation in the first place. God forbid the legislation might actually decrease cigarette sales. Then Philip Morris might not support it and the deal would crumble.
Recommendation #2: "TPSAC recommends that FDA consult with appropriate experts and carry out relevant analyses depending on the actions taken in response to this report from TPSAC."
In other words, what this is saying is: "We aren't making any recommendation here about what you should do about menthol, but in case you do decide on your own that you want to consider a menthol ban, then we recommend that you think about it carefully." Extremely helpful to the Agency. I don't think they would have thought about this had TPSAC not pointed it out.
I have to say that this is one of the most stupid processes I have observed in all my years following federal policy making and the result is as meaningless as anything I have witnessed. The report offers absolutely nothing. There is no guidance provided to the Agency. No recommendation is put forward.
The rest of the story is that TPSAC has simply punted the issue back to the FDA. They could have simply told the Agency a year ago: "We punt this back to you. We are not going to make any recommendation anyway, so we're not going to pretend to actually be carrying out a thoughtful analysis. We don't want to waste taxpayer money only to come back to you in a year and say that our conclusion is that you should consider the issues and make a decision on your own."
One of the skills I teach my students is how to write a policy memo. In such a memo, students analyze a public health policy, provide the policy options, evaluate each option, and close by making a recommendation. I have to say that if a student ever handed in a policy memo that looked like the TPSAC report, the student would fail my class. First of all, TPSAC doesn't appear to understand the difference between a conclusion and a recommendation. Second of all, the report doesn't make any recommendation. The whole point of the exercise was to offer some guidance, some suggestion for action. The report fails in that regard. In my class, that results in a failing grade. In the real-life classroom of federal public health policy making, that results in a waste of taxpayer dollars.
ADDENDUM (March 21, 2010 - 9:20 a.m.): It has been pointed out to me that the FDA's Center for Tobacco Products efforts (including expenditures on the TPSAC) are funded not by taxpayers, but by user fees assessed on cigarette companies. For this reason, it is not truly taxpayer money that I feel has been "wasted," but cigarette company user fees. This makes the issue of wasting taxpayer money a non-concern, although I still am troubled by the fact that such an intensive effort yielded, in the end, no actual recommendation for action (or non-action). Thanks to readers for pointing this out to me.
Monday, March 21, 2011
Friday, March 18, 2011
FDA Advisory Panel Does Not Recommend Menthol Ban and Warns of Potential Black Market: Huge Victory for Lorillard
In what is certainly a huge victory and sigh of relief for Lorillard, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) today released its recommendations regarding menthol cigarettes and did not directly recommend that the FDA ban these products. Instead, the Committee merely noted that banning menthol cigarettes could benefit the public's health by inducing many smokers to quit, and recommended that the FDA merely consider the issue further. Moreover, the Committee explicitly warned about the potential black market consequences that could be associated with a menthol ban and urged the FDA to carefully study such potential effects before taking any such action.
After a one sentence recommendation that states: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States," the report emphasizes that it "has no specific suggestions for follow-up by FDA to this recommendation."
The report emphasizes that "TPSAC is not proposing specific policy actions that should be taken by FDA... ."
After the one sentence "recommendation," the report then provides a full two and a half pages of details about the potential adverse effects of a menthol ban related to contraband cigarettes and a black market, and concludes that the FDA would need to carefully assess the potential for contraband menthol cigarettes.
The Rest of the Story
If I worked for Lorillard, I would be breathing a huge sigh of relief this afternoon. This is essentially a best-case scenario for Lorillard, as the the TSPAC took the least drastic action that could possibly have been expected given the make-up of the panel and the conclusions regarding the marketing and impact of menthol in its report.
Here is what TPSAC did not do:
Most importantly, the Committee did not recommend a ban on menthol cigarettes. This is a huge victory for Lorillard.
Second, the Committee did not recommend reductions in levels of menthol. Another victory for Lorillard
Third, the Committee did not recommend marketing restrictions on menthol cigarettes. Yet another victory for Lorillard.
And fourth, the Committee did not put any particular time frame or specific recommendation for action on the FDA. It merely noted that a menthol ban would benefit the public's health and leaves it at that.
Here is what TSPAC did do:
Most importantly, TPSAC gave the FDA a huge out by elaborating in detail all of the potential adverse consequences of a menthol cigarette ban.
Second, TPSAC gave the FDA the benefit of time by emphasizing the importance of further review of the possible ramifications of a menthol ban.
In essence, what the TPSAC did is what legislative committees do when they want to reject a measure without insulting its sponsors: they send it to committee for further review.
The FDA now has exactly what it needs to avoid having to take on a difficult political issue. I have made clear my opinion that the FDA is not going to ban menthol, regardless of the TPSAC recommendations, purely for political reasons. Taking on a menthol ban is the last thing in the world that the Administration needs right now, at a time when it is fighting with every last breath just to maintain the health care package that passed last year and to fend off political damage from attacks that big government has taken over health care.
The political prospects for a menthol ban were low to zero even before this report. But now, the FDA has all the justification and back-up it needs to save face even to the most staunch health advocates. The FDA can say that its expert panel warned about potential black market effects and emphasized that the Agency needs to study the issue further before taking any drastic actions.
It is important to note that all of the major conclusions of the report are things that we already knew. We didn't need a full year of research and taxpayer expenditures to find out that "Menthol cigarettes have an adverse impact on public health in the United States" (what cigarettes do not?) We also didn't need a full year of effort to conclude that "There are no public health benefits of menthol compared to non-menthol cigarettes" (what cigarettes do have benefits compared to others?).
We knew a year ago that banning menthol would have public health benefits (this is precisely why Lorillard was so worried about a potential ban).
What we didn't know a year ago was whether the TPSAC would recommend that the FDA ban menthol.
Now we know the answer. And it is a resounding NO. Although TPSAC made it clear that banning menthol would benefit the public's health, the Committee did not make such a recommendation. Instead, TPSAC swept the issue under the rug by giving the FDA an out, taking the pressure off the FDA by removing any time pressure, not calling for any specific FDA action, and emphasizing in the great detail all the potential adverse effects of a ban that the FDA must carefully study prior to implementing a ban.
The rest of the story is that TPSAC punted and Lorillard returns this punt for a touchdown.
After a one sentence recommendation that states: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States," the report emphasizes that it "has no specific suggestions for follow-up by FDA to this recommendation."
The report emphasizes that "TPSAC is not proposing specific policy actions that should be taken by FDA... ."
After the one sentence "recommendation," the report then provides a full two and a half pages of details about the potential adverse effects of a menthol ban related to contraband cigarettes and a black market, and concludes that the FDA would need to carefully assess the potential for contraband menthol cigarettes.
The Rest of the Story
If I worked for Lorillard, I would be breathing a huge sigh of relief this afternoon. This is essentially a best-case scenario for Lorillard, as the the TSPAC took the least drastic action that could possibly have been expected given the make-up of the panel and the conclusions regarding the marketing and impact of menthol in its report.
Here is what TPSAC did not do:
Most importantly, the Committee did not recommend a ban on menthol cigarettes. This is a huge victory for Lorillard.
Second, the Committee did not recommend reductions in levels of menthol. Another victory for Lorillard
Third, the Committee did not recommend marketing restrictions on menthol cigarettes. Yet another victory for Lorillard.
And fourth, the Committee did not put any particular time frame or specific recommendation for action on the FDA. It merely noted that a menthol ban would benefit the public's health and leaves it at that.
Here is what TSPAC did do:
Most importantly, TPSAC gave the FDA a huge out by elaborating in detail all of the potential adverse consequences of a menthol cigarette ban.
Second, TPSAC gave the FDA the benefit of time by emphasizing the importance of further review of the possible ramifications of a menthol ban.
In essence, what the TPSAC did is what legislative committees do when they want to reject a measure without insulting its sponsors: they send it to committee for further review.
The FDA now has exactly what it needs to avoid having to take on a difficult political issue. I have made clear my opinion that the FDA is not going to ban menthol, regardless of the TPSAC recommendations, purely for political reasons. Taking on a menthol ban is the last thing in the world that the Administration needs right now, at a time when it is fighting with every last breath just to maintain the health care package that passed last year and to fend off political damage from attacks that big government has taken over health care.
The political prospects for a menthol ban were low to zero even before this report. But now, the FDA has all the justification and back-up it needs to save face even to the most staunch health advocates. The FDA can say that its expert panel warned about potential black market effects and emphasized that the Agency needs to study the issue further before taking any drastic actions.
It is important to note that all of the major conclusions of the report are things that we already knew. We didn't need a full year of research and taxpayer expenditures to find out that "Menthol cigarettes have an adverse impact on public health in the United States" (what cigarettes do not?) We also didn't need a full year of effort to conclude that "There are no public health benefits of menthol compared to non-menthol cigarettes" (what cigarettes do have benefits compared to others?).
We knew a year ago that banning menthol would have public health benefits (this is precisely why Lorillard was so worried about a potential ban).
What we didn't know a year ago was whether the TPSAC would recommend that the FDA ban menthol.
Now we know the answer. And it is a resounding NO. Although TPSAC made it clear that banning menthol would benefit the public's health, the Committee did not make such a recommendation. Instead, TPSAC swept the issue under the rug by giving the FDA an out, taking the pressure off the FDA by removing any time pressure, not calling for any specific FDA action, and emphasizing in the great detail all the potential adverse effects of a ban that the FDA must carefully study prior to implementing a ban.
The rest of the story is that TPSAC punted and Lorillard returns this punt for a touchdown.
TPSAC Menthol Report Answers the Scientific Questions, But Doesn't Tip Committee's Hand, Demonstrating this is About Policy and Politics, Not Science
Six draft chapters of the FDA Tobacco Products Scientific Advisory Committee (TPSAC) menthol report are now available. These chapters are the following:
The Rest of the Story
That one can read essentially the full report and have no idea what the Committee will recommend demonstrates a point I have been making for some time: that the menthol issue is not a scientific one, but purely a political and policy one. In other words, science cannot determine what the nation's approach to menthol cigarettes should be. Only policy criteria and politics can make that determination. Thus, the Committee has essentially wasted a year of time and a huge amount of resources. Nothing new came out of the report. This is all information we have known for some time. The Committee could have made its recommendations a year ago, as none of these scientific findings add anything new that was necessary to contribute to a policy decision.
Put in other words, the decision about whether or not to ban menthol cigarettes is not one that flows logically from any particular scientific finding regarding menthol. What it flows from is simply two things:
1. The policy criteria that one decides to use to judge whether a cigarette flavoring should be banned; and
2. Politics.
Essentially, there are two criteria that TPSAC could use to make a decision regarding menthol:
A. A cigarette flavoring should be banned if it increases the toxicity of the product.
B. A cigarette flavoring should be banned if it contributes to increased smoking initiation or decreased smoking cessation by making smoking more appealing.
Under criterion A, menthol should not be banned because there is no evidence that menthol cigarettes are any more toxic than other cigarettes. This is something we knew a year ago before the Committee began its research and deliberations.
Under criterion B, menthol should be banned because obviously it increases the appeal of the product. The cigarette companies would not use this additive if it didn't increase the appeal of the product. That is the case with every additive. This is something we knew a year ago before the Committee began its research and deliberations.
You see, nothing happened in the past year that contributed toward the Committee's decision. What it needs to do is figure out what is the appropriate criterion to use in making a policy decision regarding menthol. This is an issue of policy, not science. Nothing that is in the report contributes towards that decision. The decision is separate from the science. You have to decide what policy criteria to use, and that doesn't have any relationship to the scientific issues. It could have been done a year ago, and no report was necessary to come to such a decision.
This is very different from an issue where the science actually dictates the decision. For example, if the FDA were deciding whether or not to approve a new drug, we could read the advisory committee's report and we would immediately know whether the committee would recommend to approve or disapprove the drug. The answer to the question would flow logically out of the conclusions in the report.
The same thing is true of an FDA panel considering whether to take a particular drug off the market. The answer flows from the scientific analysis.
The menthol issue is completely different. No clear answer flows from this scientific analysis. At the end of the day, it comes down to: What criteria are you going to use to decide the appropriate regulatory approach to menthol as a cigarette flavoring or additive? The answer to that question in no way flows from scientific information. It flows from policy judgment. Or, at worst, from political considerations.
So I find myself in the absurd situation of having no better idea (literally zero percent improvement in confidence) of what TPSAC will recommend after having read six chapters of its report than before the committee even started considering the issue.
The Committee could still recommend a ban on menthol cigarettes, regulation of menthol levels, regulation of menthol cigarette marketing, or further study. None of these policy approaches flows directly from the report's analysis of the scientific issues. It is a completely separate and different decision.
- CHAPTER 1: OVERVIEW: WHAT THIS REPORT IS ABOUT and CHAPTER 2: TPSAC’S APPROACH TO ITS CHARGE
- CHAPTER 3: THE PHYSIOLOGICAL EFFECTS OF MENTHOL CIGARETTES
- CHAPTER 4: PATTERNS OF MENTHOL CIGARETTE SMOKING
- CHAPTER 5: MARKETING AND CONSUMER PERCEPTION
- CHAPTER 7: EFFECTS OF MENTHOL ON THE DISEASE RISKS OF SMOKING
- There is no evidence that menthol cigarettes are any more hazardous than other cigarettes in terms of their health effects.
- Menthol does contribute to the smoking initiation process by masking the harsh taste of tobacco.
- Menthol cigarettes are disproportionately popular among African American smokers.
- Menthol cigarettes are marketed disproportionately to African Americans.
- The marketing messages convey that menthol cigarettes may be safer.
- Menthol cigarettes may increase the difficulty of quitting.
- The marketing of menthol cigarettes, in combination with its effects, make the product appealing, lead to a perception of relative safety compared to other cigarettes, and make the product more appealing, especially among the African American population.
The Rest of the Story
That one can read essentially the full report and have no idea what the Committee will recommend demonstrates a point I have been making for some time: that the menthol issue is not a scientific one, but purely a political and policy one. In other words, science cannot determine what the nation's approach to menthol cigarettes should be. Only policy criteria and politics can make that determination. Thus, the Committee has essentially wasted a year of time and a huge amount of resources. Nothing new came out of the report. This is all information we have known for some time. The Committee could have made its recommendations a year ago, as none of these scientific findings add anything new that was necessary to contribute to a policy decision.
Put in other words, the decision about whether or not to ban menthol cigarettes is not one that flows logically from any particular scientific finding regarding menthol. What it flows from is simply two things:
1. The policy criteria that one decides to use to judge whether a cigarette flavoring should be banned; and
2. Politics.
Essentially, there are two criteria that TPSAC could use to make a decision regarding menthol:
A. A cigarette flavoring should be banned if it increases the toxicity of the product.
B. A cigarette flavoring should be banned if it contributes to increased smoking initiation or decreased smoking cessation by making smoking more appealing.
Under criterion A, menthol should not be banned because there is no evidence that menthol cigarettes are any more toxic than other cigarettes. This is something we knew a year ago before the Committee began its research and deliberations.
Under criterion B, menthol should be banned because obviously it increases the appeal of the product. The cigarette companies would not use this additive if it didn't increase the appeal of the product. That is the case with every additive. This is something we knew a year ago before the Committee began its research and deliberations.
You see, nothing happened in the past year that contributed toward the Committee's decision. What it needs to do is figure out what is the appropriate criterion to use in making a policy decision regarding menthol. This is an issue of policy, not science. Nothing that is in the report contributes towards that decision. The decision is separate from the science. You have to decide what policy criteria to use, and that doesn't have any relationship to the scientific issues. It could have been done a year ago, and no report was necessary to come to such a decision.
This is very different from an issue where the science actually dictates the decision. For example, if the FDA were deciding whether or not to approve a new drug, we could read the advisory committee's report and we would immediately know whether the committee would recommend to approve or disapprove the drug. The answer to the question would flow logically out of the conclusions in the report.
The same thing is true of an FDA panel considering whether to take a particular drug off the market. The answer flows from the scientific analysis.
The menthol issue is completely different. No clear answer flows from this scientific analysis. At the end of the day, it comes down to: What criteria are you going to use to decide the appropriate regulatory approach to menthol as a cigarette flavoring or additive? The answer to that question in no way flows from scientific information. It flows from policy judgment. Or, at worst, from political considerations.
So I find myself in the absurd situation of having no better idea (literally zero percent improvement in confidence) of what TPSAC will recommend after having read six chapters of its report than before the committee even started considering the issue.
The Committee could still recommend a ban on menthol cigarettes, regulation of menthol levels, regulation of menthol cigarette marketing, or further study. None of these policy approaches flows directly from the report's analysis of the scientific issues. It is a completely separate and different decision.
Thursday, March 17, 2011
Safeway Lawsuit Against San Francisco Highlights the Irrationality and Lack of Public Health Basis of Pharmacy Tobacco Sales Bans
Consider the following four facts about the city of San Francisco's law which prohibits cigarette sales in certain types of stores:
ONE
San Francisco's 7-Eleven stores sell the following medicines that are designed to improve human health by helping to treat illness:
This is because Walgreen's also contain a pharmacy and the city's law prohibits the sale of tobacco products in any store that contains a pharmacy.
TWO
There are 15 Safeway grocery stores in San Francisco. At 10 of these stores, cigarettes cannot be sold. At 5 of the stores, cigarettes can be sold. They are exactly the same store: Safeway. Yet 10 can sell cigarettes and 5 cannot. Clearly, the public doesn't see these stores as being different. They are all Safeways.
To be clear:
The Safeway at 1335 Webster Street cannot sell cigarettes, but the Safeway at 350 Bay Street can.
The Safeway at 2020 Market Street cannot sell cigarettes, but the Safeway at 145 Jackson Street can.
The Safeway at 2300 16th Street cannot sell cigarettes, but the Safeway at 3350 Mission Street can.
The Safeway at 298 King Street cannot sell cigarettes, but the Safeway at 5290 Diamond Heights Boulevard can.
The Safeway at 15 Marina Boulevard cannot sell cigarettes, but the Safeway at 625 Monterey Boulevard can.
There's just one difference. According to city law, the first set of stores (Safeways) cannot sell cigarettes, but the second set of stores (Safeways) can.
THREE
The Safeway store at 145 Jackson Street offers adult immunizations. However, it is allowed to sell cigarettes.
The Safeway at 298 King Street does not offer any immunizations. However, it is not permitted to sell cigarettes.
There's just one difference. According to city law, the first store (Safeway) can sell cigarettes, but the second store (Safeway) cannot.
FOUR
The Safeway store at 145 Jackson Street sells health-related items, including medicines. In addition to offering immunizations against seasonal influenza, pneumonia, and the H1N1 virus, it sells a host of medicines, including Allegra, which (for those of you in the Bay Area), is on sale this week for $17.99 (20-count; 12-hour relief).
This store - which offers all of these immunizations and sells all of these medicines - can, by law, sell cigarettes. And it does sell cigarettes, to go with its immunizations and medicines.
The Rest of the Story
The obvious irrationality of San Francisco's law banning cigarette sales at pharmacies is readily apparent when you examine the preposterous situation it has created.
Some stores that sell medicines to help people recover from illness can sell cigarettes, while others cannot.
Some Safeways can sell cigarettes, while others cannot.
A Safeway that offers immunizations and sells medicines can sell cigarettes, while another Safeway that does not offer immunizations cannot sell cigarettes.
The city argues that the law is intended to prevent stores that sell healthful items - medications to be exact - from also selling an unhealthful item: cigarettes. However, the Safeway store at 145 Jackson Street and does offer lots of medicines as well as immunizations is allowed to sell cigarettes by this law, while its counterpart at 298 King Street which does not offer immunizations cannot sell cigarettes.
The irrationality of this law is the basis of a lawsuit that Safeway has filed against the city. A Safeway spokeswoman pointed out: "Safeway is first and foremost a retail grocery store that happens to sell health and wellness products. There are many other stores in the city that provide these same products but without a pharmacy. Yet they are still allowed to sell tobacco."
While the lawsuit may not ultimately succeed because the courts generally give wide discretion to governments when applying the rational basis test (an ordinance may discriminate against certain types of stores as long as there is some rational basis for that discrimination), it is very clear that the ordinance lacks any rational public health basis.
The rest of the story is that there is no rational public health basis for this law.
ONE
San Francisco's 7-Eleven stores sell the following medicines that are designed to improve human health by helping to treat illness:
- Aspirin (an analgesic and anti-pyretic)
- Tylenol (an anti-inflammatory drug)
- Advil (an anti-inflammatory drug)
- Claritin (an anti-histamine)
- DayQuil (a combination of analgesic, anti-pyretic, cough suppressant, and decongestant)
- NyQuil (a combination of analgesic, anti-pyretic, cough suppressant, and anti-histamine)
- Aleve (an anti-inflammatory drug)
- Motrin (an anti-inflammatory drug)
- Pepcid (a treatment for gastroesophageal reflux)
- Aspirin (an analgesic and anti-pyretic)
- Tylenol (an anti-inflammatory drug)
- Advil (an anti-inflammatory drug)
- Claritin (an anti-histamine)
- DayQuil (a combination of analgesic, anti-pyretic, cough suppressant, and decongestant)
- NyQuil (a combination of analgesic, anti-pyretic, cough suppressant, and anti-histamine)
- Aleve (an anti-inflammatory drug)
- Motrin (an anti-inflammatory drug)
- Pepcid (a treatment for gastroesophageal reflux)
This is because Walgreen's also contain a pharmacy and the city's law prohibits the sale of tobacco products in any store that contains a pharmacy.
TWO
There are 15 Safeway grocery stores in San Francisco. At 10 of these stores, cigarettes cannot be sold. At 5 of the stores, cigarettes can be sold. They are exactly the same store: Safeway. Yet 10 can sell cigarettes and 5 cannot. Clearly, the public doesn't see these stores as being different. They are all Safeways.
To be clear:
The Safeway at 1335 Webster Street cannot sell cigarettes, but the Safeway at 350 Bay Street can.
The Safeway at 2020 Market Street cannot sell cigarettes, but the Safeway at 145 Jackson Street can.
The Safeway at 2300 16th Street cannot sell cigarettes, but the Safeway at 3350 Mission Street can.
The Safeway at 298 King Street cannot sell cigarettes, but the Safeway at 5290 Diamond Heights Boulevard can.
The Safeway at 15 Marina Boulevard cannot sell cigarettes, but the Safeway at 625 Monterey Boulevard can.
There's just one difference. According to city law, the first set of stores (Safeways) cannot sell cigarettes, but the second set of stores (Safeways) can.
THREE
The Safeway store at 145 Jackson Street offers adult immunizations. However, it is allowed to sell cigarettes.
The Safeway at 298 King Street does not offer any immunizations. However, it is not permitted to sell cigarettes.
There's just one difference. According to city law, the first store (Safeway) can sell cigarettes, but the second store (Safeway) cannot.
FOUR
The Safeway store at 145 Jackson Street sells health-related items, including medicines. In addition to offering immunizations against seasonal influenza, pneumonia, and the H1N1 virus, it sells a host of medicines, including Allegra, which (for those of you in the Bay Area), is on sale this week for $17.99 (20-count; 12-hour relief).
This store - which offers all of these immunizations and sells all of these medicines - can, by law, sell cigarettes. And it does sell cigarettes, to go with its immunizations and medicines.
The Rest of the Story
The obvious irrationality of San Francisco's law banning cigarette sales at pharmacies is readily apparent when you examine the preposterous situation it has created.
Some stores that sell medicines to help people recover from illness can sell cigarettes, while others cannot.
Some Safeways can sell cigarettes, while others cannot.
A Safeway that offers immunizations and sells medicines can sell cigarettes, while another Safeway that does not offer immunizations cannot sell cigarettes.
The city argues that the law is intended to prevent stores that sell healthful items - medications to be exact - from also selling an unhealthful item: cigarettes. However, the Safeway store at 145 Jackson Street and does offer lots of medicines as well as immunizations is allowed to sell cigarettes by this law, while its counterpart at 298 King Street which does not offer immunizations cannot sell cigarettes.
The irrationality of this law is the basis of a lawsuit that Safeway has filed against the city. A Safeway spokeswoman pointed out: "Safeway is first and foremost a retail grocery store that happens to sell health and wellness products. There are many other stores in the city that provide these same products but without a pharmacy. Yet they are still allowed to sell tobacco."
While the lawsuit may not ultimately succeed because the courts generally give wide discretion to governments when applying the rational basis test (an ordinance may discriminate against certain types of stores as long as there is some rational basis for that discrimination), it is very clear that the ordinance lacks any rational public health basis.
The rest of the story is that there is no rational public health basis for this law.
Wednesday, March 16, 2011
IN MY VIEW: Society for Research on Nicotine and Tobacco (SRNT) Has Compromised Its Scientific Integrity by Accepting Pharmaceutical Money
According to its web site: "The Society for Research on Nicotine and Tobacco (SRNT) is the leading association focused on this special area of research. SRNT was founded in 1994 to coordinate and advance research on a broad array of topics ranging from the pharmacology of nicotine to the societal influences on use of tobacco.
"The mission of the Society is to stimulate the generation of new knowledge concerning nicotine in all its manifestations - from molecular to societal. The Society has three main aims:
Although its main purpose is presumably to foster objective scientific consideration of the issues regarding nicotine and tobacco control, what is not immediately apparent to web site viewers is that the Society is apparently heavily funded by the pharmaceutical industry. This funding, in my view, creates a substantial conflict of interest that precludes the objective consideration of many important scientific issues; in particular, the role of smoking cessation drugs as part of national or international tobacco control strategies.
On its web site, the Society for Research on Nicotine and Tobacco acknowledges financial support from three different pharmaceutical companies: GlaxoSmithKline, Johnson & Johnson, and Pfizer.
The 2011 annual meeting of the Society for Research on Nicotine and Tobacco, held last month in Toronto, was supported by three different pharmaceutical companies: GlaxoSmithKline, Johnson & Johnson, and Pfizer.
One way in which the conflict of interest created by these pharmaceutical sponsorships may play out is in the determination of the scientific agenda for the annual meeting. For example, while the annual meeting program highlights several talks about the benefits of Chantix (manufactured by conference sponsor Pfizer), I cannot find in the program any talk dedicated to discussing the many suicides and other serious adverse effects attributed to Chantix. I could find no paper, for example, which focuses on the reported effects of Chantix on suicidal ideation, completed suicide, or other violent behavior.
How can one expect that the Society would include in the program a talk on the hundreds of cases of violent and often fatal adverse effects that have been reported with Chantix when the drug's manufacturer is a major sponsor of the conference?
There were numerous papers presented about the effects of smoking cessation drugs. How can these papers present a completely objective picture of the efficacy of these medications when the manufacturers of these drugs are the very sponsors of the conference?
This is in no way to fault the individual scientists who presented on these issues at the conference. Nor is it to suggest that any wrongdoing occurred. It is merely to point out that the pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors.
It is also important to point out that bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.
I should also note that SRNT is not unique in relying upon pharmaceutical company sponsorship. As I noted yesterday, the 14th World Conference on Tobacco OR Health, which was held in Mumbai, India in March 2009, was sponsored by two of the largest representatives of Big Pharma: GlaxoSmithKline and Pfizer. The 2007 National Conference on Tobacco or Health was sponsored by Pfizer, as was at least one event at the 2009 Conference. And the Sixth National Conference on Tobacco or Health in Canada in 2009 was also sponsored by Pfizer.
I should once again highlight the International Society for the Prevention of Tobacco Induced Diseases (ISPTID) as one of the few national or international organizations that, despite past acceptance of sponsorships from Big Pharma, has changed and found other ways to support its annual meetings. I understand the difficulty of finding funding to support these large meetings. But it is possible to find alternative sources of funding. Failing to do so compromises the scientific integrity of these conferences.
"The mission of the Society is to stimulate the generation of new knowledge concerning nicotine in all its manifestations - from molecular to societal. The Society has three main aims:
- To sponsor scientific meetings and publications fostering the exchange of information on nicotine and tobacco.
- To encourage scientific research on public health efforts for the prevention and treatment of tobacco use.
- To provide a means by which legislative, governmental, regulatory and other public agencies can obtain expert advice and consultation on nicotine and tobacco."
Although its main purpose is presumably to foster objective scientific consideration of the issues regarding nicotine and tobacco control, what is not immediately apparent to web site viewers is that the Society is apparently heavily funded by the pharmaceutical industry. This funding, in my view, creates a substantial conflict of interest that precludes the objective consideration of many important scientific issues; in particular, the role of smoking cessation drugs as part of national or international tobacco control strategies.
On its web site, the Society for Research on Nicotine and Tobacco acknowledges financial support from three different pharmaceutical companies: GlaxoSmithKline, Johnson & Johnson, and Pfizer.
The 2011 annual meeting of the Society for Research on Nicotine and Tobacco, held last month in Toronto, was supported by three different pharmaceutical companies: GlaxoSmithKline, Johnson & Johnson, and Pfizer.
One way in which the conflict of interest created by these pharmaceutical sponsorships may play out is in the determination of the scientific agenda for the annual meeting. For example, while the annual meeting program highlights several talks about the benefits of Chantix (manufactured by conference sponsor Pfizer), I cannot find in the program any talk dedicated to discussing the many suicides and other serious adverse effects attributed to Chantix. I could find no paper, for example, which focuses on the reported effects of Chantix on suicidal ideation, completed suicide, or other violent behavior.
How can one expect that the Society would include in the program a talk on the hundreds of cases of violent and often fatal adverse effects that have been reported with Chantix when the drug's manufacturer is a major sponsor of the conference?
There were numerous papers presented about the effects of smoking cessation drugs. How can these papers present a completely objective picture of the efficacy of these medications when the manufacturers of these drugs are the very sponsors of the conference?
This is in no way to fault the individual scientists who presented on these issues at the conference. Nor is it to suggest that any wrongdoing occurred. It is merely to point out that the pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors.
It is also important to point out that bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.
I should also note that SRNT is not unique in relying upon pharmaceutical company sponsorship. As I noted yesterday, the 14th World Conference on Tobacco OR Health, which was held in Mumbai, India in March 2009, was sponsored by two of the largest representatives of Big Pharma: GlaxoSmithKline and Pfizer. The 2007 National Conference on Tobacco or Health was sponsored by Pfizer, as was at least one event at the 2009 Conference. And the Sixth National Conference on Tobacco or Health in Canada in 2009 was also sponsored by Pfizer.
I should once again highlight the International Society for the Prevention of Tobacco Induced Diseases (ISPTID) as one of the few national or international organizations that, despite past acceptance of sponsorships from Big Pharma, has changed and found other ways to support its annual meetings. I understand the difficulty of finding funding to support these large meetings. But it is possible to find alternative sources of funding. Failing to do so compromises the scientific integrity of these conferences.
Tuesday, March 15, 2011
Setting an Example for the Integrity of Tobacco Control Science by Discontinuing Sponsorship by Pharmaceutical Companies: ISPTID Leads the Way
On its 2006 annual meeting web site, the International Society for the Prevention of Tobacco Induced Diseases (ISPTID) stated that it is "a not-for-profit, academic, scientific and humanitarian organization of health professionals and scientists, independent from any industrial, political, governmental, or ideological group."
The rest of the story, however, is that this very conference - the Fifth Annual Conference of ISPTID - was, according to the web site, sponsored by Pfizer, a pharmaceutical company.
According to an article in its journal - Tobacco Induced Diseases - the Sixth Annual Meeting of the International Society for the Prevention of Tobacco Induced Diseases, held in Little Rock in 2007, was also sponsored by Pfizer.
According to the article: "Many contributors and sponsors supported this meeting impartially for its intended cause. The meeting was supported by funds from National Institutes of Health which includes support from National Institutes of Drug Abuse and National Cancer Institute. In addition, the meeting was funded by International Society for the Study of Lung Cancer. The corporate funding was received from Pfizer, Inc ... . Without their help the hosting of this meeting at this site would not have been possible. The sponsorship support helped to bring many scientists, graduate students and non-scientists all across the globe."
ISPTID emphasized that Pfizer's sponsorship was critical to the conference and that the very hosting of the meeting in Little Rock "would not have been possible" without Pfizer's support.
The sponsorship by Pfizer is particularly concerning because it creates a possible financial conflict of interest that might be viewed as interfering with the objective discussion of tobacco science issues that involve the assessment of the role of smoking cessation drugs in tobacco control. Discussions at the conference regarding the appropriate role of smoking cessation drugs in tobacco control could potentially have the appearance of being biased by the sponsorship of the conference by Pfizer. More importantly, the Pfizer sponsorship appears to have belied the claim that ISPTID was an organization fully independent of industry groups.
The Rest of the Story
Unlike many other organizations in tobacco control which apparently have not come to understand the fact that pharmaceutical industry sponsorship is problematic because it could potentially interfere with scientific integrity by creating a perceived (or real) financial conflict of interest, the International Society for the Prevention of Tobacco Induced Disease has now rejected the idea of pharmaceutical sponsorship.
Under the leadership of its new president, Dr. Taru Kinnunen, ISPTID did not take any pharmaceutical sponsorships and its most recent conferences - including the 8th annual meeting in Boston last September - have not been sponsored in any way by pharmaceutical companies.
At a time when finding funds to pay for conferences like this is getting more difficult, ISPTID - and particularly Dr. Kinnunen - are to be congratulated for taking the principled stand of not relying on pharmaceutical funding.
As I have discussed in earlier columns, in contrast to recent meetings of the ISPTID, both the World Conference on Tobacco and Health and the National Tobacco Control Conference apparently are still accepting pharmaceutical company sponsorships. The 14th World Conference on Tobacco OR Health, which was held in Mumbai, India in March 2009, was sponsored by two of the largest representatives of Big Pharma: GlaxoSmithKline and Pfizer. The 2007 National Conference on Tobacco or Health was sponsored by Pfizer, as was at least one event at the 2009 Conference. The Sixth National Conference on Tobacco or Health in Canada in 2009 was also sponsored by Pfizer.
The Society for Research on Nicotine and Tobacco (SRNT) is heavily conflicted because of its pharmaceutical sponsorship, and it continues to rely on that sponsorship. It currently acknowledges support from three different pharmaceutical companies: GlaxoSmithKline, Pfizer, and Johnson & Johnson.
Why is ISPTID one of the few national or international organizations that, despite past acceptance of sponsorships from Big Pharma, has changed and found other ways to support its annual meetings? I can only attribute that, at least in part, to the integrity and character of its leadership, including past president Dr. Taru Kinnunen, who I admire deeply for her commitment, integrity, and passion for improving the public's health, but without sacrificing scientific integrity in the process. I can only hope that more tobacco control groups will follow ISPTID’s lead.
The rest of the story, however, is that this very conference - the Fifth Annual Conference of ISPTID - was, according to the web site, sponsored by Pfizer, a pharmaceutical company.
According to an article in its journal - Tobacco Induced Diseases - the Sixth Annual Meeting of the International Society for the Prevention of Tobacco Induced Diseases, held in Little Rock in 2007, was also sponsored by Pfizer.
According to the article: "Many contributors and sponsors supported this meeting impartially for its intended cause. The meeting was supported by funds from National Institutes of Health which includes support from National Institutes of Drug Abuse and National Cancer Institute. In addition, the meeting was funded by International Society for the Study of Lung Cancer. The corporate funding was received from Pfizer, Inc ... . Without their help the hosting of this meeting at this site would not have been possible. The sponsorship support helped to bring many scientists, graduate students and non-scientists all across the globe."
ISPTID emphasized that Pfizer's sponsorship was critical to the conference and that the very hosting of the meeting in Little Rock "would not have been possible" without Pfizer's support.
The sponsorship by Pfizer is particularly concerning because it creates a possible financial conflict of interest that might be viewed as interfering with the objective discussion of tobacco science issues that involve the assessment of the role of smoking cessation drugs in tobacco control. Discussions at the conference regarding the appropriate role of smoking cessation drugs in tobacco control could potentially have the appearance of being biased by the sponsorship of the conference by Pfizer. More importantly, the Pfizer sponsorship appears to have belied the claim that ISPTID was an organization fully independent of industry groups.
The Rest of the Story
Unlike many other organizations in tobacco control which apparently have not come to understand the fact that pharmaceutical industry sponsorship is problematic because it could potentially interfere with scientific integrity by creating a perceived (or real) financial conflict of interest, the International Society for the Prevention of Tobacco Induced Disease has now rejected the idea of pharmaceutical sponsorship.
Under the leadership of its new president, Dr. Taru Kinnunen, ISPTID did not take any pharmaceutical sponsorships and its most recent conferences - including the 8th annual meeting in Boston last September - have not been sponsored in any way by pharmaceutical companies.
At a time when finding funds to pay for conferences like this is getting more difficult, ISPTID - and particularly Dr. Kinnunen - are to be congratulated for taking the principled stand of not relying on pharmaceutical funding.
As I have discussed in earlier columns, in contrast to recent meetings of the ISPTID, both the World Conference on Tobacco and Health and the National Tobacco Control Conference apparently are still accepting pharmaceutical company sponsorships. The 14th World Conference on Tobacco OR Health, which was held in Mumbai, India in March 2009, was sponsored by two of the largest representatives of Big Pharma: GlaxoSmithKline and Pfizer. The 2007 National Conference on Tobacco or Health was sponsored by Pfizer, as was at least one event at the 2009 Conference. The Sixth National Conference on Tobacco or Health in Canada in 2009 was also sponsored by Pfizer.
The Society for Research on Nicotine and Tobacco (SRNT) is heavily conflicted because of its pharmaceutical sponsorship, and it continues to rely on that sponsorship. It currently acknowledges support from three different pharmaceutical companies: GlaxoSmithKline, Pfizer, and Johnson & Johnson.
Why is ISPTID one of the few national or international organizations that, despite past acceptance of sponsorships from Big Pharma, has changed and found other ways to support its annual meetings? I can only attribute that, at least in part, to the integrity and character of its leadership, including past president Dr. Taru Kinnunen, who I admire deeply for her commitment, integrity, and passion for improving the public's health, but without sacrificing scientific integrity in the process. I can only hope that more tobacco control groups will follow ISPTID’s lead.
Monday, March 14, 2011
My Op-Ed on Pharmacy Tobacco Sales Ban Highlights How Politics, Not Public Health, is Driving Many in Tobacco Control
Those of you who read my blog post on Thursday about the Fall River (Massachusetts) City Council's initial approval of an ordinance that bans tobacco sales in stores that have pharmacies (but not in the stores from which youth are most likely to buy cigarettes) will recognize my opinion piece published yesterday by the Fall River Herald-News, to which I offered a slightly modified version of my blog commentary.
In the piece, I note - sarcastically - that the Fall River City Council is to be congratulated for sending the clear message to youth that "they want people to die of lung cancer from cigarettes purchased at gas stations and convenience stores like Honey Farms and Cumberland Farms, rather than at large chain pharmacy stores like CVS, Rite-Aid, and Walgreens. ... It is truly a tragedy when someone dies of a smoking-related illness and it turns out that their cigarettes were purchased in a pharmacy."
This action by the Fall River City Council frames smoking in exactly the wrong way. It is not a problem because cigarettes are being sold in the same store as medications. It is a problem because cigarettes are killing hundreds of thousands of Americans each year.
Moreover, the action by the Fall River City Council will have no effect on youth smoking. Kids will still be able to purchase cigarettes at numerous other stores in the city, including gas stations and convenience stores where they are already more likely to be buying their cigarettes in the first place.
This is largely a feel-good measure: a law enacted to make it look like the City Council is tackling the smoking problem, but without the policy makers having to actually take a politically difficult action that would truly make a difference in lowering Fall River's very high smoking rates. In other words, the action is essentially a political one, not a public health-based measure. The political rhetoric of the City Council members may be advanced because of the initiative, but the rate of smoking among Fall River's youth will not decline one iota because of it.
The Rest of the Story
This op-ed piece highlights a much broader issue in tobacco control, beyond merely the merit of laws that ban the sale of tobacco products in pharmacies. The piece highlights the growing trend of what one might call "political correctness" in tobacco control. By that, I mean taking actions purely for political gain, not for tangible public health benefit.
I think the term "political correctness" is widely overused. Often opponents of an action use the term to attack any policy they oppose. As I see it, political correctness is the enactment of a policy purely for political gain (i.e., public approval), devoid of any true public health or public welfare justification.
Attacking policy makers who support workplace smoking bans on the grounds that they are acting out of "political correctness" is baseless in my view, because smoking bans have tangible and substantial public health benefits. However, enacting an ordinance that makes it appear that you are addressing a problem without actually advancing the public's health - such as banning tobacco sales only in pharmacies - is an example of what might rightly be called political correctness. The policy is achieving little other than political benefit for the policy makers. There is no tangible and substantial public health benefit, as there will be no effect on overall tobacco sales. The ordinance will merely shift sales from one type of store to another.
That shifting of tobacco sales affects the profitability of various businesses, but it does not affect the public's health. Advances to the political image of policy makers is coming at the expense of a loss of business by some stores. This re-distribution of tobacco sales profits is not justified by any public health gains. The public does not benefit. The politicians who enacted the law do benefit, by virtue of improving their public image: making it look like they are taking a tough stand for the protection of the public's health.
In recent months, I have commented on a range of similar policies which share this characteristic: they are feel-good policies which allow politicians to make it look to the public like they are taking a principled stand for the public's health, but which in fact have no significant public health benefits.
Examples include the following:
The rest of the story is that there has been a disappointing and unfortunate shift in tobacco control activities: away from measures that may be less politically popular but which are evidence-based and actually make a difference in reducing smoking rates and towards measures that are politically popular but do little or nothing to reduce the burden of tobacco-related morbidity and mortality.
In the piece, I note - sarcastically - that the Fall River City Council is to be congratulated for sending the clear message to youth that "they want people to die of lung cancer from cigarettes purchased at gas stations and convenience stores like Honey Farms and Cumberland Farms, rather than at large chain pharmacy stores like CVS, Rite-Aid, and Walgreens. ... It is truly a tragedy when someone dies of a smoking-related illness and it turns out that their cigarettes were purchased in a pharmacy."
This action by the Fall River City Council frames smoking in exactly the wrong way. It is not a problem because cigarettes are being sold in the same store as medications. It is a problem because cigarettes are killing hundreds of thousands of Americans each year.
Moreover, the action by the Fall River City Council will have no effect on youth smoking. Kids will still be able to purchase cigarettes at numerous other stores in the city, including gas stations and convenience stores where they are already more likely to be buying their cigarettes in the first place.
This is largely a feel-good measure: a law enacted to make it look like the City Council is tackling the smoking problem, but without the policy makers having to actually take a politically difficult action that would truly make a difference in lowering Fall River's very high smoking rates. In other words, the action is essentially a political one, not a public health-based measure. The political rhetoric of the City Council members may be advanced because of the initiative, but the rate of smoking among Fall River's youth will not decline one iota because of it.
The Rest of the Story
This op-ed piece highlights a much broader issue in tobacco control, beyond merely the merit of laws that ban the sale of tobacco products in pharmacies. The piece highlights the growing trend of what one might call "political correctness" in tobacco control. By that, I mean taking actions purely for political gain, not for tangible public health benefit.
I think the term "political correctness" is widely overused. Often opponents of an action use the term to attack any policy they oppose. As I see it, political correctness is the enactment of a policy purely for political gain (i.e., public approval), devoid of any true public health or public welfare justification.
Attacking policy makers who support workplace smoking bans on the grounds that they are acting out of "political correctness" is baseless in my view, because smoking bans have tangible and substantial public health benefits. However, enacting an ordinance that makes it appear that you are addressing a problem without actually advancing the public's health - such as banning tobacco sales only in pharmacies - is an example of what might rightly be called political correctness. The policy is achieving little other than political benefit for the policy makers. There is no tangible and substantial public health benefit, as there will be no effect on overall tobacco sales. The ordinance will merely shift sales from one type of store to another.
That shifting of tobacco sales affects the profitability of various businesses, but it does not affect the public's health. Advances to the political image of policy makers is coming at the expense of a loss of business by some stores. This re-distribution of tobacco sales profits is not justified by any public health gains. The public does not benefit. The politicians who enacted the law do benefit, by virtue of improving their public image: making it look like they are taking a tough stand for the protection of the public's health.
In recent months, I have commented on a range of similar policies which share this characteristic: they are feel-good policies which allow politicians to make it look to the public like they are taking a principled stand for the public's health, but which in fact have no significant public health benefits.
Examples include the following:
- New York City's law requiring graphic warning posters at cigarette point-of-sale
- San Francisco's law banning Happy Meals (toy giveaways with certain foods marketed to children)
- New York City's ban on flavored tobacco products
- The Family Smoking Prevention and Tobacco Control Act
- The Framework Convention on Tobacco Control's proposed cigarette ingredient regulations
- The Framework Convention's proposed approach to regulating cigarette additives
- Washington state tobacco control groups' support for a law banning menthol cigarillos
- The FDA's ban on flavored cigarettes
- The American Lung Association's call for initiatives to reduce the burden of lung cancer among African Americans
The rest of the story is that there has been a disappointing and unfortunate shift in tobacco control activities: away from measures that may be less politically popular but which are evidence-based and actually make a difference in reducing smoking rates and towards measures that are politically popular but do little or nothing to reduce the burden of tobacco-related morbidity and mortality.
Thursday, March 10, 2011
Dishonest Disclosures? Six Articles on Health Effects of Hookah Use Fail to Mention that Research Sponsor Was Directed by a Tobacco Industry Executive
Six different papers on hookah (also called waterpipe, shisha, or narghile) use, published between 2008 and 2010 and funded by the International Development Research Centre, failed to report any conflicts of interest. The papers, their funding sources, and their conflict of interest statements, are as follows:
1. Al Rashidi M, Shihadeh A, Saliba NA. Volatile aldehydes in the mainstream smoke of the narghile waterpipe. Food and Chemical Toxicology. 2008 Nov;46(11):3546-9.
Funding source: International Development Research Centre and National Cancer Institute
Conflict of interest statement: "The authors declare that there are no conflicts of interest."
2. Monzer B, Sepetdjian E, Saliba N, Shihadeh A. Charcoal emissions as a source of CO and carcinogenic PAH in mainstream narghile waterpipe smoke. Food and Chemical Toxicology. 2008 Sep;46(9):2991-5.
Funding source: International Development Research Centre and University Research Board at the American University of Beirut
Conflict of interest statement: "The authors declare that there are no conflicts of interest."
3. Saleh R, Shihadeh A. Elevated toxicant yields with narghile waterpipes smoked using a plastic hose. Food and Chemical Toxicology. 2008 May;46(5):1461-6.
Funding source: International Development Research Centre and University Research Board at the American University of Beirut
Conflict of interest statement: "We have no conflict of interest in connection with the
research reported in this manuscript."
4. Sepetdjian E, Shihadeh A, Saliba NA. Measurement of 16 polycyclic aromatic hydrocarbons in narghile waterpipe tobacco smoke. Food and Chemical Toxicology. 2008 May;46(5):1582-90.
Funding source: International Development Research Centre and University Research Board at the American University of Beirut
Conflict of interest statement: "Nothing to declare."
5. Daher N, Saleh R, Jaroudi E, Sheheitli H, Badr T, Sepetdjian E, Al-Rashidi M, Saliba N, Shihadeh A. Comparison of carcinogen, carbon monoxide, and ultrafine particle emissions from narghile waterpipe and cigarette smoking: Sidestream smoke measurements and assessment of second-hand smoke emission factors. Atmospheric Environment 2010; 44(1): 8-14.
Funding source: International Development Research Centre and U.S. Public Health Service.
Conflict of interest statement: None.
6. Khalil J, Heath RL, Nakkash RT, Afifi RA. The tobacco health nexus? Health messages in narghile advertisements. Tobacco Control. 2009 Oct;18(5):420-1.
Funding source: International Development Research Centre
Conflict of interest statement: "None."
The Rest of the Story
What none of these papers disclose is that there is a significant conflict of interest:
The work was funded by an organization that is directed by a Chair who, at the time of the research and publications, was a tobacco industry executive.
The Chair of the International Development Research Centre is Barbara McDougall. Mrs. McDougall joined the Board in January 2007 and since December 2007 has directed the organization, serving as its Chairman.
Although her biography on the IDRC web site does not mention it, McDougall was, until last March, a tobacco industry executive.
From October 2004 to March 2010, McDougall was on the Board of Directors of Imperial Tobacco Company, which is owned by British American Tobacco. She served as the Chair of the Imperial Tobacco Canada Corporate Social Responsibility Committee, whose job it was to make it look like Imperial Tobacco is a socially responsible company, when in fact the company is the leading cause of cancer and heart disease in Canada.
Her 2006-2007 report starts by pretending that: "Being a socially responsible company is a top priority at Imperial Tobacco Canada." Obviously, that's a big lie, as Imperial continued to sell deadly tobacco products which serve as the leading cause of preventable deaths in all of Canada. In many respects, I view the insincere and fake efforts to make Imperial Tobacco to look socially responsible to be even more reprehensible than the actual production of cigarettes.
At any rate, the rest of the story is that despite the lack of any disclosed conflicts of interest, all of the above research was funded by an organization directed by a tobacco industry executive.
I therefore view these disclosures as being inaccurate and untruthful. Wouldn't it be important for the public to know that an article which compares the risks of hookah use with the use of cigarettes and other tobacco products was funded by an organization run by a tobacco industry executive? And not just any tobacco executive, but someone on the Board of Directors of the leading tobacco company in all of Canada.
I think it is shameful not to have such an important piece of information disclosed in these research articles. This is especially true since the conflict of interest could easily be perceived as affecting the conduct and reporting of the research findings. After all, hookah use is a potential competitor to the use of cigarettes and other tobacco products and Imperial Tobacco has a direct financial interest in the results of this research on the relative health effects of hookah use compared to the products which Imperial produces, markets, sells, and relies upon for its profits.
To not let readers of these articles know that the research sponsor was (at the time) run by a tobacco industry executive is irresponsible and undermines the purpose of conflict of interest disclosures.
Apparently, some or all of the researchers were not aware of this conflict of interest at the time they submitted their papers to the journals. A more recent article published by many of the same authors does disclose that the International Development Research Centre was chaired by a tobacco industry executive: "Revelations regarding IDRC Chairperson Barbara McDougall’s unfortunate ties to the tobacco industry were not known to the authors of this study at the time it was funded and executed". Strangely, however, the papers still state: "All other authors declare that they have no conflicts of interest."
I don't understand how they can make this statement. It can't be both ways. If the research sponsor was directed by a tobacco industry executive, then the researchers are conflicted, and that conflict needs to be disclosed. The fact that they did not know who the Chair of the Board was does not remove the conflict. Nor does the conflict mean that the researchers were biased. But the bias may come in at a higher level. For example, in the very decisions about what research to fund in the first place, having a tobacco industry executive as the Chair of the Board may influence those decisions. Studying hookah use seems to be a wise decision for a tobacco company Chair because it would help deflect attention of her products and put them onto hookah, a potential competitor.
Many researchers do not understand that a financial conflict of interest is not assessed by whether the researcher is biased or not. A researcher can be biased without any conflict of interest and a researcher could be unbiased with a serious conflict of interest. The presence of a conflict is assessed objectively by the financial relationships of the researcher and research sponsor. In this case, it is clear that there is an important conflict of interest. It doesn't mean the investigators were biased. It simply means that there is a financial conflict of interest which is relevant, and ethical considerations require that the conflict be disclosed to readers.
I want to make two other important points. First, although the investigators cannot be blamed, in some sense, for not disclosing the conflict because they apparently did not know about it, I would argue that there is some responsibility on their part because they should have known about it. I believe that when a researcher accepts funding from an organization, it is incumbent upon the researcher to understand who he or she is taking money from.
Second, these failed disclosures are not all in the past. While the PDF versions of the article can perhaps not be changed, the HTML versions of these articles certainly can be changed, and the conflict of interest statements could easily be updated, revised, or replaced. An erratum statement could easily be published noting the new information and the presence of a conflict. In other words, this is not just a mistake that happened in the past. It is, in a sense, an ongoing one.
It is important to point out that conflicts of interest are important not only in research that denies the health effects of tobacco products. Conflicts of interest are important in all research, even if it is reporting that tobacco use is harmful.
Finally, I should make it absolutely clear that I am making no statement about the merits of the findings of these articles. In no way should this commentary be construed as defending or supporting hookah use. In fact, this commentary is not about hookah use, it is about conflict of interest and the revelation of what appears to be a widespread failure on the part of six articles to disclose an important conflict in the research.
1. Al Rashidi M, Shihadeh A, Saliba NA. Volatile aldehydes in the mainstream smoke of the narghile waterpipe. Food and Chemical Toxicology. 2008 Nov;46(11):3546-9.
Funding source: International Development Research Centre and National Cancer Institute
Conflict of interest statement: "The authors declare that there are no conflicts of interest."
2. Monzer B, Sepetdjian E, Saliba N, Shihadeh A. Charcoal emissions as a source of CO and carcinogenic PAH in mainstream narghile waterpipe smoke. Food and Chemical Toxicology. 2008 Sep;46(9):2991-5.
Funding source: International Development Research Centre and University Research Board at the American University of Beirut
Conflict of interest statement: "The authors declare that there are no conflicts of interest."
3. Saleh R, Shihadeh A. Elevated toxicant yields with narghile waterpipes smoked using a plastic hose. Food and Chemical Toxicology. 2008 May;46(5):1461-6.
Funding source: International Development Research Centre and University Research Board at the American University of Beirut
Conflict of interest statement: "We have no conflict of interest in connection with the
research reported in this manuscript."
4. Sepetdjian E, Shihadeh A, Saliba NA. Measurement of 16 polycyclic aromatic hydrocarbons in narghile waterpipe tobacco smoke. Food and Chemical Toxicology. 2008 May;46(5):1582-90.
Funding source: International Development Research Centre and University Research Board at the American University of Beirut
Conflict of interest statement: "Nothing to declare."
5. Daher N, Saleh R, Jaroudi E, Sheheitli H, Badr T, Sepetdjian E, Al-Rashidi M, Saliba N, Shihadeh A. Comparison of carcinogen, carbon monoxide, and ultrafine particle emissions from narghile waterpipe and cigarette smoking: Sidestream smoke measurements and assessment of second-hand smoke emission factors. Atmospheric Environment 2010; 44(1): 8-14.
Funding source: International Development Research Centre and U.S. Public Health Service.
Conflict of interest statement: None.
6. Khalil J, Heath RL, Nakkash RT, Afifi RA. The tobacco health nexus? Health messages in narghile advertisements. Tobacco Control. 2009 Oct;18(5):420-1.
Funding source: International Development Research Centre
Conflict of interest statement: "None."
The Rest of the Story
What none of these papers disclose is that there is a significant conflict of interest:
The work was funded by an organization that is directed by a Chair who, at the time of the research and publications, was a tobacco industry executive.
The Chair of the International Development Research Centre is Barbara McDougall. Mrs. McDougall joined the Board in January 2007 and since December 2007 has directed the organization, serving as its Chairman.
Although her biography on the IDRC web site does not mention it, McDougall was, until last March, a tobacco industry executive.
From October 2004 to March 2010, McDougall was on the Board of Directors of Imperial Tobacco Company, which is owned by British American Tobacco. She served as the Chair of the Imperial Tobacco Canada Corporate Social Responsibility Committee, whose job it was to make it look like Imperial Tobacco is a socially responsible company, when in fact the company is the leading cause of cancer and heart disease in Canada.
Her 2006-2007 report starts by pretending that: "Being a socially responsible company is a top priority at Imperial Tobacco Canada." Obviously, that's a big lie, as Imperial continued to sell deadly tobacco products which serve as the leading cause of preventable deaths in all of Canada. In many respects, I view the insincere and fake efforts to make Imperial Tobacco to look socially responsible to be even more reprehensible than the actual production of cigarettes.
At any rate, the rest of the story is that despite the lack of any disclosed conflicts of interest, all of the above research was funded by an organization directed by a tobacco industry executive.
I therefore view these disclosures as being inaccurate and untruthful. Wouldn't it be important for the public to know that an article which compares the risks of hookah use with the use of cigarettes and other tobacco products was funded by an organization run by a tobacco industry executive? And not just any tobacco executive, but someone on the Board of Directors of the leading tobacco company in all of Canada.
I think it is shameful not to have such an important piece of information disclosed in these research articles. This is especially true since the conflict of interest could easily be perceived as affecting the conduct and reporting of the research findings. After all, hookah use is a potential competitor to the use of cigarettes and other tobacco products and Imperial Tobacco has a direct financial interest in the results of this research on the relative health effects of hookah use compared to the products which Imperial produces, markets, sells, and relies upon for its profits.
To not let readers of these articles know that the research sponsor was (at the time) run by a tobacco industry executive is irresponsible and undermines the purpose of conflict of interest disclosures.
Apparently, some or all of the researchers were not aware of this conflict of interest at the time they submitted their papers to the journals. A more recent article published by many of the same authors does disclose that the International Development Research Centre was chaired by a tobacco industry executive: "Revelations regarding IDRC Chairperson Barbara McDougall’s unfortunate ties to the tobacco industry were not known to the authors of this study at the time it was funded and executed". Strangely, however, the papers still state: "All other authors declare that they have no conflicts of interest."
I don't understand how they can make this statement. It can't be both ways. If the research sponsor was directed by a tobacco industry executive, then the researchers are conflicted, and that conflict needs to be disclosed. The fact that they did not know who the Chair of the Board was does not remove the conflict. Nor does the conflict mean that the researchers were biased. But the bias may come in at a higher level. For example, in the very decisions about what research to fund in the first place, having a tobacco industry executive as the Chair of the Board may influence those decisions. Studying hookah use seems to be a wise decision for a tobacco company Chair because it would help deflect attention of her products and put them onto hookah, a potential competitor.
Many researchers do not understand that a financial conflict of interest is not assessed by whether the researcher is biased or not. A researcher can be biased without any conflict of interest and a researcher could be unbiased with a serious conflict of interest. The presence of a conflict is assessed objectively by the financial relationships of the researcher and research sponsor. In this case, it is clear that there is an important conflict of interest. It doesn't mean the investigators were biased. It simply means that there is a financial conflict of interest which is relevant, and ethical considerations require that the conflict be disclosed to readers.
I want to make two other important points. First, although the investigators cannot be blamed, in some sense, for not disclosing the conflict because they apparently did not know about it, I would argue that there is some responsibility on their part because they should have known about it. I believe that when a researcher accepts funding from an organization, it is incumbent upon the researcher to understand who he or she is taking money from.
Second, these failed disclosures are not all in the past. While the PDF versions of the article can perhaps not be changed, the HTML versions of these articles certainly can be changed, and the conflict of interest statements could easily be updated, revised, or replaced. An erratum statement could easily be published noting the new information and the presence of a conflict. In other words, this is not just a mistake that happened in the past. It is, in a sense, an ongoing one.
It is important to point out that conflicts of interest are important not only in research that denies the health effects of tobacco products. Conflicts of interest are important in all research, even if it is reporting that tobacco use is harmful.
Finally, I should make it absolutely clear that I am making no statement about the merits of the findings of these articles. In no way should this commentary be construed as defending or supporting hookah use. In fact, this commentary is not about hookah use, it is about conflict of interest and the revelation of what appears to be a widespread failure on the part of six articles to disclose an important conflict in the research.
Wednesday, March 09, 2011
Fall River Tells Youth: We Want You to Die of Lung Cancer from Cigarettes Purchased at Convenience Stores and Gas Stations, Not at Larger Chain Stores
In a clear message to the youth of the city, the Fall River (Massachusetts) City Council indicated that they want people to die of lung cancer from cigarettes purchased at gas stations and convenience stores like Honey Farms and Cumberland Farms, rather than at large chain pharmacy stores like CVS, Rite-Aid, and Walgreen's.
According to an article in the Fall River Herald-News, the Fall River City Council last night approved the first reading of an ordinance that would ban the sale of tobacco products in all pharmacies. The ordinance would, however, continue to allow the sale of these dangerous products in all other types of stores, including the ones where youth are most likely to purchase them: gas stations and small convenience stores.
According to the article: "Passage would mean a CVS or Wal-Mart can’t sell cigarettes anywhere in the store because they operate a pharmacy. ... Proponents said such an ordinance was necessary with city smoking at twice the state average."
The Rest of the Story
It's great to see policy makers taking a strong, principled stand and sending a clear message to youth: better that people should get lung cancer and emphysema from cigarettes purchased at smaller stores than from cigarettes purchased from larger ones, especially from those that have pharmacies.
It is gratifying to see these policy makers standing up and reminding our youth that when someone dies of lung cancer due to Marlboros that were purchased at CVS, it is a terrible, preventable tragedy, but when someone dies of cancer caused by Marlboros purchased at Honey Farms, it is perfectly acceptable.
It is also great to see these policy makers intervening in exactly the stores where restricting tobacco sales will have the least effect on youth access to tobacco. The large chain stores, especially the big pharmacies, are the ones which have the most rigorous training of their clerks and the lowest rate of cigarette sales to minors. It is precisely the stores that were exempted - the small convenience stores and gas stations - where youth can most easily purchase cigarettes. So it's nice to see that the policy makers are taking the action that will have the least possible effect on protecting youth from the devastating effects of cigarette smoking.
While the policy makers say they are acting to avoid a mixed message, it's nice to see that they are sending a very mixed message themselves: that we should judge the acceptability of selling cancer-causing products to people based on whether a store also sells medicine or not. This is an important lesson that I think all children should be taught.
We definitely don't want children to think that it is acceptable to sell deadly products and medicine at the same time. We want children to understand that as long as you don't sell medicine, it is perfectly acceptable to sell products that kill hundreds of thousands of Americans each year. How shameful it is of pharmacies to sell tobacco. And how admirable it is to see small convenience stores which sell tobacco but do not send mixed messages by also selling medicine.
What will be the next step that the Fall River City Council takes? To offer an award to its 7-Eleven for not stooping to the unethical level of also selling medicine with its cigarettes? To congratulate its Store 24 for only selling cigarettes, and not prescription drugs? To give the owner of Xtra Mart the key to the city for not sending a mixed message to young people by having medical products in the store when they purchase their cigarettes? To put a placard outside Cumberland Farms that says: "We are a model retail establishment. We don't mix the sale of medicines with our cigarette sales"?
The Fall River City Council should really give a special award to the Old Firehouse Smoke Shop. What a model citizen. What a great example for the youth. What a great symbol of the promotion of the public's health. After all, not only does the Smoke Shop not sell medicines, it also doesn't sell anything else other than tobacco products. Thus, there is no possible mixed message here.
Azore Discount Tobacco should also get an award from the Council. They have "tobacco" right in the name of their store, so they represent pure tobacco product sales, unadulterated by offering any other products that could possibly be construed as being of health value.
Hopefully, cities throughout the country will follow Fall River's honorable example. It is truly a tragedy when someone dies of a smoking-related illness and it turns out that their cigarettes were purchased in a pharmacy.
According to an article in the Fall River Herald-News, the Fall River City Council last night approved the first reading of an ordinance that would ban the sale of tobacco products in all pharmacies. The ordinance would, however, continue to allow the sale of these dangerous products in all other types of stores, including the ones where youth are most likely to purchase them: gas stations and small convenience stores.
According to the article: "Passage would mean a CVS or Wal-Mart can’t sell cigarettes anywhere in the store because they operate a pharmacy. ... Proponents said such an ordinance was necessary with city smoking at twice the state average."
The Rest of the Story
It's great to see policy makers taking a strong, principled stand and sending a clear message to youth: better that people should get lung cancer and emphysema from cigarettes purchased at smaller stores than from cigarettes purchased from larger ones, especially from those that have pharmacies.
It is gratifying to see these policy makers standing up and reminding our youth that when someone dies of lung cancer due to Marlboros that were purchased at CVS, it is a terrible, preventable tragedy, but when someone dies of cancer caused by Marlboros purchased at Honey Farms, it is perfectly acceptable.
It is also great to see these policy makers intervening in exactly the stores where restricting tobacco sales will have the least effect on youth access to tobacco. The large chain stores, especially the big pharmacies, are the ones which have the most rigorous training of their clerks and the lowest rate of cigarette sales to minors. It is precisely the stores that were exempted - the small convenience stores and gas stations - where youth can most easily purchase cigarettes. So it's nice to see that the policy makers are taking the action that will have the least possible effect on protecting youth from the devastating effects of cigarette smoking.
While the policy makers say they are acting to avoid a mixed message, it's nice to see that they are sending a very mixed message themselves: that we should judge the acceptability of selling cancer-causing products to people based on whether a store also sells medicine or not. This is an important lesson that I think all children should be taught.
We definitely don't want children to think that it is acceptable to sell deadly products and medicine at the same time. We want children to understand that as long as you don't sell medicine, it is perfectly acceptable to sell products that kill hundreds of thousands of Americans each year. How shameful it is of pharmacies to sell tobacco. And how admirable it is to see small convenience stores which sell tobacco but do not send mixed messages by also selling medicine.
What will be the next step that the Fall River City Council takes? To offer an award to its 7-Eleven for not stooping to the unethical level of also selling medicine with its cigarettes? To congratulate its Store 24 for only selling cigarettes, and not prescription drugs? To give the owner of Xtra Mart the key to the city for not sending a mixed message to young people by having medical products in the store when they purchase their cigarettes? To put a placard outside Cumberland Farms that says: "We are a model retail establishment. We don't mix the sale of medicines with our cigarette sales"?
The Fall River City Council should really give a special award to the Old Firehouse Smoke Shop. What a model citizen. What a great example for the youth. What a great symbol of the promotion of the public's health. After all, not only does the Smoke Shop not sell medicines, it also doesn't sell anything else other than tobacco products. Thus, there is no possible mixed message here.
Azore Discount Tobacco should also get an award from the Council. They have "tobacco" right in the name of their store, so they represent pure tobacco product sales, unadulterated by offering any other products that could possibly be construed as being of health value.
Hopefully, cities throughout the country will follow Fall River's honorable example. It is truly a tragedy when someone dies of a smoking-related illness and it turns out that their cigarettes were purchased in a pharmacy.
Tuesday, March 08, 2011
The Rest of the Story Issues Corrective Statements for Anti-Smoking Groups
Misleading, deceiving, and lying to the American public about tobacco science issues - and thus the need for corrective statements - is not restricted to the tobacco companies and the federal government. Today, I issue my proposed corrective statements for a number of anti-smoking groups which have also deceived the American people or even lied to us about the health effects of secondhand smoke (albeit in the opposite direction from the tobacco companies). Nevertheless, a lie is a lie so here is my list of proposed corrective statements.
Corrective Statement #1: (for Americans for Nonsmokers' Rights)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we lied to you about the effects of a brief exposure to secondhand smoke, telling you that a 30-minute exposure causes heart damage similar to that in habitual smokers. Here's the truth:
Corrective Statement #2: (for Action on Smoking and Health)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we lied to you about the effects of a brief exposure to secondhand smoke, telling you that a 30-minute exposure puts a nonsmoker at the same risk of a fatal heart attack as a chronic, active smoker. Here's the truth:
Corrective Statement #3: (for University of California, San Francisco/TobaccoScam)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we lied to you about the effects of a brief exposure to secondhand smoke, telling you that a mere 20-minute exposure to tobacco smoke is equivalent to smoking a pack a day. We also told you that 30-minutes of secondhand smoke exposure results in clogged arteries. Here's the truth:
Corrective Statement #4: (for The Campaign for Tobacco-Free Kids)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we deceived you about the effects of a brief exposure to secondhand smoke, telling you that 30 minutes of exposure to secondhand smoke increases the risk of a heart attack. Here's the truth:
Corrective Statement #5: (for Clean Air for Everyone - Iowa)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we lied to you about the effects of a brief exposure to secondhand smoke, telling you that a 30-minute exposure causes nonsmokers to develop heart disease. Here's the truth:
Corrective Statement #1: (for Americans for Nonsmokers' Rights)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we lied to you about the effects of a brief exposure to secondhand smoke, telling you that a 30-minute exposure causes heart damage similar to that in habitual smokers. Here's the truth:
- Heart damage is caused by heart attacks that arise due to atherosclerotic heart disease. This takes many years to develop. A single 30-minute exposure cannot cause heart disease; thus, it cannot cause heart damage.
- If it were even possible that 30 minutes of exposure to secondhand smoke could cause heart damage, the IRB at the institution doing the research we are citing to support our statement would never have approved the research.
Corrective Statement #2: (for Action on Smoking and Health)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we lied to you about the effects of a brief exposure to secondhand smoke, telling you that a 30-minute exposure puts a nonsmoker at the same risk of a fatal heart attack as a chronic, active smoker. Here's the truth:
- Heart attacks are caused by atherosclerotic heart disease. This takes many years to develop. A single 30-minute exposure cannot cause heart disease.
- Active smoking conveys a far greater risk of a heart attack than a simple 30-minute exposure to secondhand smoke. The risks are not even comparable.
- For a nonsmoker without severe, pre-existing heart disease, there is no evidence that a 30-minute exposure to secondhand smoke can cause a heart disease; moreover, it is not even plausible that such an effect could occur.
Corrective Statement #3: (for University of California, San Francisco/TobaccoScam)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we lied to you about the effects of a brief exposure to secondhand smoke, telling you that a mere 20-minute exposure to tobacco smoke is equivalent to smoking a pack a day. We also told you that 30-minutes of secondhand smoke exposure results in clogged arteries. Here's the truth:
- Smoking a pack of cigarettes per day is far worse than merely being exposed to secondhand smoke for 20 minutes. The risks are not even comparable.
- A 30-minute exposure to secondhand smoke does not result in clogged arteries. It takes many years of exposure before the heart disease process progresses enough to result in clogged arteries.
Corrective Statement #4: (for The Campaign for Tobacco-Free Kids)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we deceived you about the effects of a brief exposure to secondhand smoke, telling you that 30 minutes of exposure to secondhand smoke increases the risk of a heart attack. Here's the truth:
- In an otherwise healthy person, 30 minutes of secondhand smoke exposure is not going to cause a heart attack.
- There is no scientific evidence that a 30 minute exposure to secondhand smoke increases heart attack risk in anyone other than people with severe, pre-existing coronary artery disease.
Corrective Statement #5: (for Clean Air for Everyone - Iowa)
Corrective Statement Regarding Cardiovascular Effects of Brief Secondhand Smoke Exposure
For years, we lied to you about the effects of a brief exposure to secondhand smoke, telling you that a 30-minute exposure causes nonsmokers to develop heart disease. Here's the truth:
- A single 30-minute exposure cannot cause heart disease.
- Our statement implied that everyone in the U.S. who has been exposed to secondhand smoke for 30 minutes or more has heart disease. This is untrue. If it were true, everyone in the U.S. would have heart disease.
Monday, March 07, 2011
Rest of the Story Proposes Corrective Statements for Federal Government
In the wake of the release of the Department of Justice's proposed corrective statements for the tobacco companies, The Rest of the Story is today proposing its own corrective statements for the federal government. Like the tobacco industry corrective statements, these statements are intended to correct the damage to the public's appreciation of critical factual issues in the area of tobacco science that have resulted from lies and deception propagated by the federal government. (Disclaimer: This idea is not my own. Jacob Sullum has opined about the need for federal government corrective statements here).
The DOJ's proposed corrective statements do not merely present factual information to the public. Each of the statements has a long "preamble" in which the tobacco companies are forced to admit their past wrongdoing, including having lied to the public. In fact, the tobacco companies have submitted a challenge to these proposed statements, arguing that they violate the D.C. appellate court's requirement that the corrective statements be restricted to factual and uncontroversial information, that they violate the First Amendment by requiring the tobacco companies to declare wrongdoing that they do not admit they conducted, and that they violate due process by compelling the companies, under threat of contempt, to admit wrongdoing in statements that could then be used by plaintiffs in other courts as evidence of alleged wrongdoing. In adherence to the DOJ's style of including such prefatory statements in their proposed corrective statements, I include such prefatory clauses here.
The evidence regarding the lies and deception of the federal government with regard to each of the issues below (each is addressed in a corrective statement) is presented in the following links:
1. FDA's Deception Regarding the Presence of Carcinogens in Electronic Cigarettes: The FDA scared the public and implied that electronic cigarettes present a substantial risk of cancer to users by reporting its laboratory finding that electronic cigarettes are dangerous because they contain carcinogens. The FDA failed to inform the public about the level of carcinogens they detected and how it compares to the level of tobacco-specific nitrosamines in regular cigarettes and in nicotine replacement products. The truth is that the FDA found only trace levels of carcinogens, comparable to those found in nicotine patches and nicotine gum, and orders of magnitude below the levels of these same carcinogens in regular cigarettes.
2. Surgeon General's Lies Regarding the Cardiovascular Effects of Brief Tobacco Smoke Exposure: The U.S. Surgeon General's office lied by stating that: "Even brief exposure to secondhand smoke can cause cardiovascular disease... ." This is not true. It takes many years of tobacco smoke exposure to cause atherosclerosis, even among active smokers.
3. Surgeon General's Deception Regarding the Carcinogenic Risk Presented by a Brief Tobacco Smoke Exposure: The U.S. Surgeon General's office deceived the public by stating that: "Inhaling even the smallest amount of tobacco smoke can ... lead to cancer." There is no scientific evidence to support this claim. Although the Surgeon General scared the public into thinking that a single puff on a cigarette could cause cancer, the office provided no evidence that this have ever actually occurred.
4. Federal Trade Commission's Deception Regarding the Health Benefits of Lower Nicotine and Tar Yields: The federal government bears some responsibility in the deception of smokers about the safety of using low-tar and light cigarettes. The Federal Trade Commission, which has assumed jurisdiction over the tar and nicotine content of cigarettes and the advertising of cigarettes with regard to this content, has failed in its regulatory efforts. The deception of smokers is not just in the hands of the cigarette companies. It is also in the hands of the federal government, for assuming jurisdiction over, but failing miserably to address the advertising of tar and nicotine levels to smokers. In fact, the federal government has knowingly misled smokers for years by requiring labeling that is inherently deceptive. The cigarette companies have been required by law to provide these deceptive figures.
5. FDA's Deception Regarding Flavored Cigarettes Being a Gateway to Addiction for Youth: The FDA deceived the American public by stating that "flavored cigarettes are a gateway for many children and young adults to become regular smokers." The truth is that almost no children or young adults progress to regular smoking by virtue of starting with flavored cigarettes. Such cigarettes were almost entirely taken off the market years ago and at the time the statement was made, the consumption of flavored cigarettes by youth was below 0.1% of the market.
6. DHHS's Deception Regarding Flavored Cigarettes Being a Gateway to Addiction for Youth: The Department of Health and Human Services deceived the American public by stating that "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily." The truth is that almost no children or young adults progress to regular smoking by virtue of starting with flavored cigarettes. Such cigarettes were almost entirely taken off the market years ago and at the time the statement was made, the consumption of flavored cigarettes by youth was below 0.1% of the market. The FDA's ban on flavored cigarettes will have no appreciable impact on youth smoking initiation. Thus, it will not break the cycle of addiction for more than 3,600 young people who start smoking daily.
The Rest of the Story
Proposed Corrective Statement #1: (for the FDA)
Corrective Statement for FDA's Deception Regarding the Presence of Carcinogens in Electronic Cigarettes
We are being required to tell the truth about our laboratory findings regarding the detection of carcinogens in electronic cigarettes. We told you that electronic cigarettes contain carcinogens but we deceived you by not revealing the level and by not comparing it to that of regular cigarettes or nicotine replacement products. Here's the truth:
Proposed Corrective Statement #2: (for the Surgeon General's Office)
Corrective Statement for Surgeon General's Lies About the Cardiovascular Effects of Brief Secondhand Smoke Exposure
We told the American people that even a single, brief exposure to secondhand smoke is enough to cause atherosclerosis and heart disease. Here's the truth:
Proposed Corrective Statement #3: (for the Surgeon General's Office)
Corrective Statement for Surgeon General's Deception About the Carcinogenic Risk Presented by a Brief Secondhand Smoke Exposure
We told the American people that even a single, brief exposure to secondhand smoke is enough to cause cancer. Here's the truth:
Proposed Corrective Statement #4: (for FTC)
Corrective Statement for Lack of Health Benefit from Low Yield Cigarettes
By requiring the meaningless disclosure of nicotine and tar yields on cigarette packs, we falsely suggested to the public that low tar and light cigarettes are less harmful than regular cigarettes. This kept people smoking and helped sustain the profits of the tobacco companies.
We knew that many smokers switch to low tar and light cigarettes rather than quitting because they believe low tar and lights are less harmful. They are NOT.
We also knew that the tar and nicotine ratings we required of cigarette companies were meaningless and that the machines used to derive these ratings do not simulate actual human smoking behavior. Yet for decades, we required the tobacco companies to furnish this misleading and meaningless information.
Here’s the truth:
Proposed Corrective Statement #5: (for FDA)
Corrective Statement for Deception Regarding Flavored Cigarettes Being a Gateway to Addiction Among Youth
We told you that flavored cigarettes are a gateway to life-long addiction among youth. We implied that if flavored cigarettes were taken off the market, the problem of cigarette smoking among youth would be greatly reduced. Here's the truth:
Proposed Corrective Statement #6: (for DHHS)
Corrective Statement for Deception Regarding Flavored Cigarettes Being a Gateway to Addiction Among Youth
We told you that flavored cigarettes are a gateway to life-long addiction among youth. We said that if flavored cigarettes were taken off the market, the problem of cigarette smoking among youth would be greatly reduced. Here's the truth:
The DOJ's proposed corrective statements do not merely present factual information to the public. Each of the statements has a long "preamble" in which the tobacco companies are forced to admit their past wrongdoing, including having lied to the public. In fact, the tobacco companies have submitted a challenge to these proposed statements, arguing that they violate the D.C. appellate court's requirement that the corrective statements be restricted to factual and uncontroversial information, that they violate the First Amendment by requiring the tobacco companies to declare wrongdoing that they do not admit they conducted, and that they violate due process by compelling the companies, under threat of contempt, to admit wrongdoing in statements that could then be used by plaintiffs in other courts as evidence of alleged wrongdoing. In adherence to the DOJ's style of including such prefatory statements in their proposed corrective statements, I include such prefatory clauses here.
The evidence regarding the lies and deception of the federal government with regard to each of the issues below (each is addressed in a corrective statement) is presented in the following links:
1. FDA's Deception Regarding the Presence of Carcinogens in Electronic Cigarettes: The FDA scared the public and implied that electronic cigarettes present a substantial risk of cancer to users by reporting its laboratory finding that electronic cigarettes are dangerous because they contain carcinogens. The FDA failed to inform the public about the level of carcinogens they detected and how it compares to the level of tobacco-specific nitrosamines in regular cigarettes and in nicotine replacement products. The truth is that the FDA found only trace levels of carcinogens, comparable to those found in nicotine patches and nicotine gum, and orders of magnitude below the levels of these same carcinogens in regular cigarettes.
2. Surgeon General's Lies Regarding the Cardiovascular Effects of Brief Tobacco Smoke Exposure: The U.S. Surgeon General's office lied by stating that: "Even brief exposure to secondhand smoke can cause cardiovascular disease... ." This is not true. It takes many years of tobacco smoke exposure to cause atherosclerosis, even among active smokers.
3. Surgeon General's Deception Regarding the Carcinogenic Risk Presented by a Brief Tobacco Smoke Exposure: The U.S. Surgeon General's office deceived the public by stating that: "Inhaling even the smallest amount of tobacco smoke can ... lead to cancer." There is no scientific evidence to support this claim. Although the Surgeon General scared the public into thinking that a single puff on a cigarette could cause cancer, the office provided no evidence that this have ever actually occurred.
4. Federal Trade Commission's Deception Regarding the Health Benefits of Lower Nicotine and Tar Yields: The federal government bears some responsibility in the deception of smokers about the safety of using low-tar and light cigarettes. The Federal Trade Commission, which has assumed jurisdiction over the tar and nicotine content of cigarettes and the advertising of cigarettes with regard to this content, has failed in its regulatory efforts. The deception of smokers is not just in the hands of the cigarette companies. It is also in the hands of the federal government, for assuming jurisdiction over, but failing miserably to address the advertising of tar and nicotine levels to smokers. In fact, the federal government has knowingly misled smokers for years by requiring labeling that is inherently deceptive. The cigarette companies have been required by law to provide these deceptive figures.
5. FDA's Deception Regarding Flavored Cigarettes Being a Gateway to Addiction for Youth: The FDA deceived the American public by stating that "flavored cigarettes are a gateway for many children and young adults to become regular smokers." The truth is that almost no children or young adults progress to regular smoking by virtue of starting with flavored cigarettes. Such cigarettes were almost entirely taken off the market years ago and at the time the statement was made, the consumption of flavored cigarettes by youth was below 0.1% of the market.
6. DHHS's Deception Regarding Flavored Cigarettes Being a Gateway to Addiction for Youth: The Department of Health and Human Services deceived the American public by stating that "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily." The truth is that almost no children or young adults progress to regular smoking by virtue of starting with flavored cigarettes. Such cigarettes were almost entirely taken off the market years ago and at the time the statement was made, the consumption of flavored cigarettes by youth was below 0.1% of the market. The FDA's ban on flavored cigarettes will have no appreciable impact on youth smoking initiation. Thus, it will not break the cycle of addiction for more than 3,600 young people who start smoking daily.
The Rest of the Story
Proposed Corrective Statement #1: (for the FDA)
Corrective Statement for FDA's Deception Regarding the Presence of Carcinogens in Electronic Cigarettes
We are being required to tell the truth about our laboratory findings regarding the detection of carcinogens in electronic cigarettes. We told you that electronic cigarettes contain carcinogens but we deceived you by not revealing the level and by not comparing it to that of regular cigarettes or nicotine replacement products. Here's the truth:
- We found only trace levels of tobacco-specific nitrosamines in electronic cigarettes, comparable to those found in FDA-approved nicotine replacement products like nicotine patches and nicotine gum.
- The levels of carcinogens we detected in electronic cigarettes are orders of magnitude lower than in regular cigarettes, indicating that electronic cigarettes are likely much safer than regular cigarettes in terms of cancer risk.
- The minute levels of tobacco-specific nitrosamines in electronic cigarettes are a necessary result of the extraction of nicotine from tobacco. Overall, these devices deliver nicotine with only a few other chemicals, compared to the delivery of nicotine plus tens of thousands of chemicals and more than 60 proven carcinogens in regular cigarettes.
Proposed Corrective Statement #2: (for the Surgeon General's Office)
Corrective Statement for Surgeon General's Lies About the Cardiovascular Effects of Brief Secondhand Smoke Exposure
We told the American people that even a single, brief exposure to secondhand smoke is enough to cause atherosclerosis and heart disease. Here's the truth:
- It takes many years of tobacco smoke exposure to develop atherosclerosis and heart disease, even among active smokers.
- You cannot develop heart disease from just a single, brief exposure to secondhand smoke.
Proposed Corrective Statement #3: (for the Surgeon General's Office)
Corrective Statement for Surgeon General's Deception About the Carcinogenic Risk Presented by a Brief Secondhand Smoke Exposure
We told the American people that even a single, brief exposure to secondhand smoke is enough to cause cancer. Here's the truth:
- It takes a substantial amount of tobacco smoke exposure to develop cancer. There is no evidence that a single puff on a cigarette is sufficient to cause cancer, and we are not aware of any specific cases in which this has occurred.
- Cancer risk among those exposed to secondhand smoke is linearly related to the overall amount of lifetime exposure. It is extremely unlikely that a single, brief exposure to secondhand smoke would cause cancer.
Proposed Corrective Statement #4: (for FTC)
Corrective Statement for Lack of Health Benefit from Low Yield Cigarettes
By requiring the meaningless disclosure of nicotine and tar yields on cigarette packs, we falsely suggested to the public that low tar and light cigarettes are less harmful than regular cigarettes. This kept people smoking and helped sustain the profits of the tobacco companies.
We knew that many smokers switch to low tar and light cigarettes rather than quitting because they believe low tar and lights are less harmful. They are NOT.
We also knew that the tar and nicotine ratings we required of cigarette companies were meaningless and that the machines used to derive these ratings do not simulate actual human smoking behavior. Yet for decades, we required the tobacco companies to furnish this misleading and meaningless information.
Here’s the truth:
- Just because lights and low tar cigarettes have lower FTC-required ratings, that doesn’t mean they are any better for you. Light cigarettes can deliver the same amounts of tar and nicotine as regular cigarettes.
- ALL cigarettes cause cancer, lung disease, heart attacks and premature death—lights, low tar, ultra lights, and naturals. Lower FTC-required tar and nicotine ratings do not mean any lower risk of disease.
Proposed Corrective Statement #5: (for FDA)
Corrective Statement for Deception Regarding Flavored Cigarettes Being a Gateway to Addiction Among Youth
We told you that flavored cigarettes are a gateway to life-long addiction among youth. We implied that if flavored cigarettes were taken off the market, the problem of cigarette smoking among youth would be greatly reduced. Here's the truth:
- At the time we made the statement, flavored cigarettes made up less than 0.1% of the youth market.
- Taking the few remaining flavored cigarette brands off the market will have no appreciable effect on youth smoking.
- It is the non-flavored brands - the Marlboros, Camels, and Newports - which are responsible for almost all youth addiction to cigarettes.
- The only flavoring that is significantly contributing to youth addiction - menthol - is the one flavoring which has been exempted from the FDA's ban on flavored cigarettes.
Proposed Corrective Statement #6: (for DHHS)
Corrective Statement for Deception Regarding Flavored Cigarettes Being a Gateway to Addiction Among Youth
We told you that flavored cigarettes are a gateway to life-long addiction among youth. We said that if flavored cigarettes were taken off the market, the problem of cigarette smoking among youth would be greatly reduced. Here's the truth:
- At the time we made the statement, flavored cigarettes made up less than 0.1% of the youth market.
- Taking the few remaining flavored cigarette brands off the market will have no appreciable effect on youth smoking.
- It is the non-flavored brands - the Marlboros, Camels, and Newports - which are responsible for almost all youth addiction to cigarettes.
- The only flavoring that is significantly contributing to youth addiction - menthol - is the one flavoring which has been exempted from the FDA's ban on flavored cigarettes.
Thursday, March 03, 2011
Despite Its Current Rhetoric, Campaign for Tobacco-Free Kids Stood With Tobacco Industry in Opposing Menthol Ban Because of Black Market Concerns
In response to the lawsuit brought by Lorillard and R.J. Reynolds against the FDA to prevent the agency from receiving a menthol report from its Tobacco Products Scientific Advisory Committee (TPSAC), the Campaign for Tobacco-Free Kids attacked these tobacco companies, arguing that they are "putting profits ahead of lives and health."
What few people know, however, is that the Campaign for Tobacco-Free Kids itself put politics ahead of lives and health when it opposed an amendment that would have removed the menthol exemption from the cigarette flavoring ban. Moreover, the Campaign used the same argument that Lorillard is now putting forward to stave off a ban: that such a ban would result in a black market which would itself have negative public health consequences.
Here is what the Campaign argued, in its own words: "Unlike the candy flavors, there's more than 10 million people in the United States who smoke menthol cigarettes. If you immediately withdrew a product so many people use and are addicted to, you can't say for certain what the reaction would be. Would these smokers look to get their fix from other nonmentholated cigarettes or would they start to use another substance?" The Campaign also warned of the possibility of "illegal trafficking in menthol cigarettes."
The Rest of the Story
The rest of the story is that the Campaign for Tobacco-Free Kids had its opportunity to advocate for a ban on menthol cigarettes. Instead of standing up to save "lives and health" and to put lives and health first, the Campaign lobbied against removing the menthol exemption, arguing that a menthol ban could result in a black market and associated negative consequences.
The truth, then, is that the Campaign for Tobacco-Free Kids is full of crap. They are attacking the tobacco companies for putting other interests above lives and health, but they did exactly the same thing when they helped make sure that a ban on menthol would never see the light of day.
Let's face it. The only chance that a menthol ban would have had of being implemented is if it had been included in the Family Smoking Prevention and Tobacco Control Act. That is where the battle over menthol was fought, and lost. Sadly, the Campaign for Tobacco-Free Kids fought on the side of Big Tobacco.
What few people know, however, is that the Campaign for Tobacco-Free Kids itself put politics ahead of lives and health when it opposed an amendment that would have removed the menthol exemption from the cigarette flavoring ban. Moreover, the Campaign used the same argument that Lorillard is now putting forward to stave off a ban: that such a ban would result in a black market which would itself have negative public health consequences.
Here is what the Campaign argued, in its own words: "Unlike the candy flavors, there's more than 10 million people in the United States who smoke menthol cigarettes. If you immediately withdrew a product so many people use and are addicted to, you can't say for certain what the reaction would be. Would these smokers look to get their fix from other nonmentholated cigarettes or would they start to use another substance?" The Campaign also warned of the possibility of "illegal trafficking in menthol cigarettes."
The Rest of the Story
The rest of the story is that the Campaign for Tobacco-Free Kids had its opportunity to advocate for a ban on menthol cigarettes. Instead of standing up to save "lives and health" and to put lives and health first, the Campaign lobbied against removing the menthol exemption, arguing that a menthol ban could result in a black market and associated negative consequences.
The truth, then, is that the Campaign for Tobacco-Free Kids is full of crap. They are attacking the tobacco companies for putting other interests above lives and health, but they did exactly the same thing when they helped make sure that a ban on menthol would never see the light of day.
Let's face it. The only chance that a menthol ban would have had of being implemented is if it had been included in the Family Smoking Prevention and Tobacco Control Act. That is where the battle over menthol was fought, and lost. Sadly, the Campaign for Tobacco-Free Kids fought on the side of Big Tobacco.
Wednesday, March 02, 2011
FDA Advisory Panel Concludes that Menthol Cigarettes are No More Hazardous, But That They Enhance Smoking Initiation By Masking Harshness of Tobacco
In what many are viewing as a "split decision" on menthol, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) has concluded that while menthol cigarettes are no more hazardous than non-menthol cigarettes, they may contribute to smoking initiation by masking the harshness of tobacco. These conclusions are expressed in a draft report on menthol that was made available on the TPSAC web site in advance of its meeting today to discuss the menthol report which is due March 23.
In its draft of Chapter 6 of the report, TPSAC reviews the evidence on whether menthol cigarettes are more hazardous than non-menthol cigarettes, including smoking typology, biomarker, toxicology, and epidemiologic studies. The Committee concludes that:
1. "The evidence is insufficient to conclude that it is more likely than not that menthol cigarette smokers inhale more smoke than non‐menthol cigarette smokers."
2. "The evidence is insufficient to conclude that it is more likely than not that menthol cigarette smokers are exposed to higher levels of nicotine and other tobacco smoke toxins, at least in regular daily smokers of more than 5 or 10 cigarettes per day. There are insufficient data to know if among smokers of relatively few cigarettes per day menthol cigarettes result in greater smoke intake and more exposure to tobacco smoke toxins."
3. "The evidence is insufficient to conclude that smokers of menthol cigarettes face a different risk of tobacco‐caused diseases than smokers of non‐menthol cigarettes."
On the other hand, in Chapter 3 of its draft report, TPSAC reviews evidence regarding whether menthol may enhance the smoking initiation and maintenance processes by masking the harsh taste of tobacco. That chapter concludes that:
1. "The evidence is sufficient to conclude that menthol has cooling and anesthetic effects that reduce the harshness of cigarette smoke."
2. "The evidence is sufficient to conclude that menthol makes low‐tar, low‐nicotine cigarettes more acceptable to smokers. Like nicotine, menthol has irritant effects that contribute to the impact or “throat grab,” of tobacco smoke. In light or ultralight cigarettes with lower nicotine delivery, menthol can be used to provide impact. Thus menthol is likely to make low yield cigarettes more satisfying, and smokers who switch to low yield cigarettes for health concerns may be more likely to continue to smoke rather than quit."
3. "The evidence is sufficient to conclude that it is biological plausible that menthol makes cigarette smoking more addictive."
The Rest of the Story
First of all, there is nothing new or unexpected here. I could have told you all of this eight months ago, when the committee first began its deliberations. In fact, I did argue months ago that the Committee's recommendations on menthol ultimately rest on the criteria it uses to assess menthol policy. If the Committee's decision is based on whether menthol cigarettes are more hazardous than non-menthol cigarettes, I argued that it would not be able to recommend a menthol ban because there is no evidence to support such an assertion. If the Committee's decision is based on whether menthol makes cigarettes more palatable because it is an appealing flavoring, then there would be grounds to ban menthol, I argued, because there is little doubt that menthol enhances the cigarette smoking experience (if it didn't, there would be no menthol cigarettes).
Of course, the fact that I came to these conclusions months ago speaks to the tremendous waste of time and resources involved in the TPSAC and its "investigation." As I have argued, this ultimately is not an issue of science, but of policy and ultimately, politics.
From a policy perspective, the Family Smoking Prevention and Tobacco Control Act takes the position that if a flavoring makes cigarettes more appealing it must be banned. That's why the Act banned strawberry, chocolate, mint, cherry, pineapple, vanilla, coconut, banana, raspberry, blackberry, licorice, grape, pina colada, lime, and snozzberry cigarettes. Of course, the Act didn't ban menthol not for any science or policy reason, but simply because none of its supporters had the political courage to actually go up against Big Tobacco in any meaningful way.
Thus, the FDA was left in the untenable position of having to pretend to "analyze" the menthol issue from a scientific perspective to determine an appropriate policy for menthol cigarettes. Yet the issue is not a scientific one, and it never was.
The issue is two-fold:
1. On what criterion should the FDA make a decision about whether or not to ban menthol?
2. Does the FDA (and the Administration) have the political fortitude to actually ban menthol if that is the policy recommended by the advisory committee?
It is not clear what the criterion should be for the FDA to decide whether to ban menthol. If the FDA applies the criterion that was used to ban the other cigarette flavorings (i.e., whether the flavorings might enhance the taste of the product), then it would be forced to ban menthol cigarettes. In fact, the FDA would also be forced to ban all cigarette flavorings and additives, since all of them are added to enhance the ultimate bottom line: the quality and appeal of the smoking experience. If the product's appeal were not enhanced by an additive, then that additive would not be added. This is a tautological issue, not a legitimate scientific question.
If the FDA applies the criterion suggested by Lorillard - that to be banned, menthol cigarettes must be more hazardous than non-menthol cigarettes - then the FDA would have no grounds to ban menthol cigarettes.
Ultimately, however, it doesn't matter what the TPSAC recommends. The ultimate decision by FDA will be made on political grounds. Does the FDA, and the Administration, have the courage and willingness to stand up to Big Tobacco and to political attacks if it pulls the plug from under Lorillard and a huge segment of the cigarette industry?
Given the way President Obama is already backing out of his own health care legislation, it is pretty clear that the Administration will not have the least desire to tackle a menthol ban. It is having a hard enough time defending the idea that insurance companies should not be able to deny coverage for people with pre-existing health conditions. The last thing it needs right now is to add a menthol cigarette ban to the list of initiatives that the Republican-led House will try to repeal.
The rest of the story is that the TPSAC's almost year-long consideration of menthol is a tremendous waste of time and taxpayer resources. The issue is simply one of policy and politics and it didn't require a long, expensive scientific review. In fact, Congress has already declared the criterion that it thinks ought to be used to make the decision; it just didn't have the political courage to actually carry it out. It's leaving the dirty work for the FDA specifically because it knows that the Administration will have no part of owning a decision to ban menthol.
In fact, this is what the plan was for the Tobacco Act's supporters (including the anti-smoking groups) from the very start:
1. Make it look like you really care about youth smoking by banning all the flavors that aren't actually used.
2. Pretend that there will be a meaningful process of reviewing scientific issues regarding menthol.
3. Regardless of the final report of the advisory committee, rest assured that the Administration will not take on ownership of a menthol ban.
4. Sleep well at night, knowing that you got political brownie points for "helping save the children" without actually having to stand up to Big Tobacco.
In its draft of Chapter 6 of the report, TPSAC reviews the evidence on whether menthol cigarettes are more hazardous than non-menthol cigarettes, including smoking typology, biomarker, toxicology, and epidemiologic studies. The Committee concludes that:
1. "The evidence is insufficient to conclude that it is more likely than not that menthol cigarette smokers inhale more smoke than non‐menthol cigarette smokers."
2. "The evidence is insufficient to conclude that it is more likely than not that menthol cigarette smokers are exposed to higher levels of nicotine and other tobacco smoke toxins, at least in regular daily smokers of more than 5 or 10 cigarettes per day. There are insufficient data to know if among smokers of relatively few cigarettes per day menthol cigarettes result in greater smoke intake and more exposure to tobacco smoke toxins."
3. "The evidence is insufficient to conclude that smokers of menthol cigarettes face a different risk of tobacco‐caused diseases than smokers of non‐menthol cigarettes."
On the other hand, in Chapter 3 of its draft report, TPSAC reviews evidence regarding whether menthol may enhance the smoking initiation and maintenance processes by masking the harsh taste of tobacco. That chapter concludes that:
1. "The evidence is sufficient to conclude that menthol has cooling and anesthetic effects that reduce the harshness of cigarette smoke."
2. "The evidence is sufficient to conclude that menthol makes low‐tar, low‐nicotine cigarettes more acceptable to smokers. Like nicotine, menthol has irritant effects that contribute to the impact or “throat grab,” of tobacco smoke. In light or ultralight cigarettes with lower nicotine delivery, menthol can be used to provide impact. Thus menthol is likely to make low yield cigarettes more satisfying, and smokers who switch to low yield cigarettes for health concerns may be more likely to continue to smoke rather than quit."
3. "The evidence is sufficient to conclude that it is biological plausible that menthol makes cigarette smoking more addictive."
The Rest of the Story
First of all, there is nothing new or unexpected here. I could have told you all of this eight months ago, when the committee first began its deliberations. In fact, I did argue months ago that the Committee's recommendations on menthol ultimately rest on the criteria it uses to assess menthol policy. If the Committee's decision is based on whether menthol cigarettes are more hazardous than non-menthol cigarettes, I argued that it would not be able to recommend a menthol ban because there is no evidence to support such an assertion. If the Committee's decision is based on whether menthol makes cigarettes more palatable because it is an appealing flavoring, then there would be grounds to ban menthol, I argued, because there is little doubt that menthol enhances the cigarette smoking experience (if it didn't, there would be no menthol cigarettes).
Of course, the fact that I came to these conclusions months ago speaks to the tremendous waste of time and resources involved in the TPSAC and its "investigation." As I have argued, this ultimately is not an issue of science, but of policy and ultimately, politics.
From a policy perspective, the Family Smoking Prevention and Tobacco Control Act takes the position that if a flavoring makes cigarettes more appealing it must be banned. That's why the Act banned strawberry, chocolate, mint, cherry, pineapple, vanilla, coconut, banana, raspberry, blackberry, licorice, grape, pina colada, lime, and snozzberry cigarettes. Of course, the Act didn't ban menthol not for any science or policy reason, but simply because none of its supporters had the political courage to actually go up against Big Tobacco in any meaningful way.
Thus, the FDA was left in the untenable position of having to pretend to "analyze" the menthol issue from a scientific perspective to determine an appropriate policy for menthol cigarettes. Yet the issue is not a scientific one, and it never was.
The issue is two-fold:
1. On what criterion should the FDA make a decision about whether or not to ban menthol?
2. Does the FDA (and the Administration) have the political fortitude to actually ban menthol if that is the policy recommended by the advisory committee?
It is not clear what the criterion should be for the FDA to decide whether to ban menthol. If the FDA applies the criterion that was used to ban the other cigarette flavorings (i.e., whether the flavorings might enhance the taste of the product), then it would be forced to ban menthol cigarettes. In fact, the FDA would also be forced to ban all cigarette flavorings and additives, since all of them are added to enhance the ultimate bottom line: the quality and appeal of the smoking experience. If the product's appeal were not enhanced by an additive, then that additive would not be added. This is a tautological issue, not a legitimate scientific question.
If the FDA applies the criterion suggested by Lorillard - that to be banned, menthol cigarettes must be more hazardous than non-menthol cigarettes - then the FDA would have no grounds to ban menthol cigarettes.
Ultimately, however, it doesn't matter what the TPSAC recommends. The ultimate decision by FDA will be made on political grounds. Does the FDA, and the Administration, have the courage and willingness to stand up to Big Tobacco and to political attacks if it pulls the plug from under Lorillard and a huge segment of the cigarette industry?
Given the way President Obama is already backing out of his own health care legislation, it is pretty clear that the Administration will not have the least desire to tackle a menthol ban. It is having a hard enough time defending the idea that insurance companies should not be able to deny coverage for people with pre-existing health conditions. The last thing it needs right now is to add a menthol cigarette ban to the list of initiatives that the Republican-led House will try to repeal.
The rest of the story is that the TPSAC's almost year-long consideration of menthol is a tremendous waste of time and taxpayer resources. The issue is simply one of policy and politics and it didn't require a long, expensive scientific review. In fact, Congress has already declared the criterion that it thinks ought to be used to make the decision; it just didn't have the political courage to actually carry it out. It's leaving the dirty work for the FDA specifically because it knows that the Administration will have no part of owning a decision to ban menthol.
In fact, this is what the plan was for the Tobacco Act's supporters (including the anti-smoking groups) from the very start:
1. Make it look like you really care about youth smoking by banning all the flavors that aren't actually used.
2. Pretend that there will be a meaningful process of reviewing scientific issues regarding menthol.
3. Regardless of the final report of the advisory committee, rest assured that the Administration will not take on ownership of a menthol ban.
4. Sleep well at night, knowing that you got political brownie points for "helping save the children" without actually having to stand up to Big Tobacco.
Tuesday, March 01, 2011
Predictably Irrational: Campaign for Tobacco-Free Kids Blasts Reynolds/Lorillard for "Groundless" Lawsuit, But Fails to Defend Conflicts of Interest
In response to the lawsuit brought by R.J. Reynolds and Lorillard against the FDA to prevent it from relying on recommendations from an advisory panel which the tobacco company plaintiffs argue is impermissibly constituted due to the financial conflicts of interest of three panelists with pharmaceutical companies that manufacture smoking cessation drugs, the Campaign for Tobacco-Free Kids has attacked these companies, accusing them of acting the way they have for decades and asserting that the lawsuit is groundless.
The entirety of the Campaign for Tobacco-Free Kids' argument for why the financial conflicts of interest of three advisory committee members is permissible under the law is as follows: "Their lawsuit is groundless. The FDA's Tobacco Products Scientific Advisory Committee was constituted and is acting in accordance with the 2009 law granting the FDA authority over tobacco products, as well as other relevant federal laws."
The Rest of the Story
As usual, the Campaign for Tobacco-Free Kids is issuing propaganda devoid of any solid argumentation. There is a serious issue that needs to be addressed and rather than presenting an argument for why it is permissible to have conflicted panelists on an FDA advisory committee, the Campaign is falling back on its usual rhetoric.
Despite the Campaign for Tobacco-Free Kids' knee-jerk dismissal of the lawsuit, the complaint puts forward a very serious issue: Are we serious about ensuring that federal advisory panels make their recommendations based on an impartial review of the science, rather than under the influence of financial conflicts of interests of the panelists?
In this case, three of the TPSAC members - Drs. Henningfield, Samet, and Benowitz - have severe financial conflicts of interest with Big Pharma. They have served as consultants to, or received funding from, pharmaceutical companies that manufacture smoking cessation drugs. The financial interest of these companies is directly affected by the recommendations that TPSAC is going to put forward on a number of items already on its agenda, including menthol and dissolvable tobacco products.
For example, a menthol ban would be a financial boost for smoking cessation drug companies. As many people affected by the menthol ban would attempt to quit smoking, such a ban would yield a direct financial benefit to companies that manufacture smoking cessation drugs. Thus, it is unacceptable to have panelists who have financial interests in these companies.
Similarly, with dissolvable tobacco products, a ban on these products would be in the best financial interests of pharmaceutical companies that manufacture smoking cessation drugs. As dissolvable tobacco products could serve as a potential competitor (these products could be marketed to help smokers quit using cigarettes), they are a potential threat to smoking cessation drugs. Once again, it is unacceptable to have panelists who have financial interests in these companies.
Rather than directly address this critical issue and explain why it believes that these severe financial conflicts of interest are permissible under the Federal Advisory Committee Act, the Campaign for Tobacco-Free Kids has relied upon its usual propaganda and rhetoric. That rhetoric may have worked years ago, but we are now living in a new era, when (ironically, thanks to the Campaign for Tobacco-Free Kids), tobacco companies are now under federal regulation. And with federal regulation, the law must be obeyed. This is what the Campaign appears to fail to understand. Ironically, this is the Campaign's own doing, as it is the Campaign which promoted the Family Smoking Prevention and Tobacco Control Act in the first place, putting the tobacco companies under federal regulation and thus giving them the protection of the laws that govern federal regulation-making.
The magnitude of the problem is perhaps illustrated best by the fact that GlaxoSmithKline has intervened directly with the FDA, urging the Agency to take dissolvable tobacco products off the market. How then, can the FDA allow a GlaxoSmithKline consultant (Henningfield) to be a part of the decision-making process on whether dissolvable tobacco products will be banned? This is every bit as bad a conflict as having a drug company consultant on an FDA advisory panel that is making a recommendation on the approval of a drug made by that company.
The entirety of the Campaign for Tobacco-Free Kids' argument for why the financial conflicts of interest of three advisory committee members is permissible under the law is as follows: "Their lawsuit is groundless. The FDA's Tobacco Products Scientific Advisory Committee was constituted and is acting in accordance with the 2009 law granting the FDA authority over tobacco products, as well as other relevant federal laws."
The Rest of the Story
As usual, the Campaign for Tobacco-Free Kids is issuing propaganda devoid of any solid argumentation. There is a serious issue that needs to be addressed and rather than presenting an argument for why it is permissible to have conflicted panelists on an FDA advisory committee, the Campaign is falling back on its usual rhetoric.
Despite the Campaign for Tobacco-Free Kids' knee-jerk dismissal of the lawsuit, the complaint puts forward a very serious issue: Are we serious about ensuring that federal advisory panels make their recommendations based on an impartial review of the science, rather than under the influence of financial conflicts of interests of the panelists?
In this case, three of the TPSAC members - Drs. Henningfield, Samet, and Benowitz - have severe financial conflicts of interest with Big Pharma. They have served as consultants to, or received funding from, pharmaceutical companies that manufacture smoking cessation drugs. The financial interest of these companies is directly affected by the recommendations that TPSAC is going to put forward on a number of items already on its agenda, including menthol and dissolvable tobacco products.
For example, a menthol ban would be a financial boost for smoking cessation drug companies. As many people affected by the menthol ban would attempt to quit smoking, such a ban would yield a direct financial benefit to companies that manufacture smoking cessation drugs. Thus, it is unacceptable to have panelists who have financial interests in these companies.
Similarly, with dissolvable tobacco products, a ban on these products would be in the best financial interests of pharmaceutical companies that manufacture smoking cessation drugs. As dissolvable tobacco products could serve as a potential competitor (these products could be marketed to help smokers quit using cigarettes), they are a potential threat to smoking cessation drugs. Once again, it is unacceptable to have panelists who have financial interests in these companies.
Rather than directly address this critical issue and explain why it believes that these severe financial conflicts of interest are permissible under the Federal Advisory Committee Act, the Campaign for Tobacco-Free Kids has relied upon its usual propaganda and rhetoric. That rhetoric may have worked years ago, but we are now living in a new era, when (ironically, thanks to the Campaign for Tobacco-Free Kids), tobacco companies are now under federal regulation. And with federal regulation, the law must be obeyed. This is what the Campaign appears to fail to understand. Ironically, this is the Campaign's own doing, as it is the Campaign which promoted the Family Smoking Prevention and Tobacco Control Act in the first place, putting the tobacco companies under federal regulation and thus giving them the protection of the laws that govern federal regulation-making.
The magnitude of the problem is perhaps illustrated best by the fact that GlaxoSmithKline has intervened directly with the FDA, urging the Agency to take dissolvable tobacco products off the market. How then, can the FDA allow a GlaxoSmithKline consultant (Henningfield) to be a part of the decision-making process on whether dissolvable tobacco products will be banned? This is every bit as bad a conflict as having a drug company consultant on an FDA advisory panel that is making a recommendation on the approval of a drug made by that company.
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