Wednesday, November 30, 2005

When You Don't Like What You Hear, Attack the Messenger - But Don't Discuss the Issues

In response to my post yesterday which provided a detailed analysis questioning the claim that smoking bans lead to immediate and drastic reductions in heart attacks, a prominent anti-smoking advocate publicly attacked me as follows:

"My general approach has been to ignore Michael Siegel, but his latest "analysis" is just too strange. He is publicising a "study" on the "Smokers' Club" web site. This "study" does not even account for population growth and there are no controls ... but only Mike can tell real quality."

The Rest of the Story

First of all, had the advocate taken the time to actually read and think about what I wrote instead of simply publicly attacking me, he or she would have noted that I was not relying upon the Smokers' Club web site study, but that I analyzed the data myself. It is my analysis (and not just what Michael McFadden and David Kuneman did) that suggests that there has been no observable (or at least no substantial) decline in heart attack admissions due to state-wide smoking bans. Even if I had relied upon the Kuneman-McFadden study without performing my own analysis, I would argue that it isn't invalidated because of who the authors are, but that it needs to be examined based on the actual data it presents. But this analysis is not going to be shot down on the basis of its authors being affiliated with the Smoker's Club, because I stand by the analysis, I think it is entirely an appropriate one (certainly with my extensions that extended the baseline period and used two comparison groups), and I think it demonstrates that there simply was not a dramatic decline in hospital admissions following the implementation of state-wide smoking bans.

Second of all, there is simply no way that population growth can account for the failure to observe a 27% to 40% decline in heart attack admissions (or even half of that) if one existed. Plus, if population growth were explaining the failure to detect such an effect, then there would have had to be basically at least a 13% difference in population growth between the smoking ban and comparison states and that difference would have had to be systematically different between the two groups.

Third of all, had the advocate read and thought about my comments before attacking me, he or she would have noted that I did employ 2 comparison groups - first, all of the states in the HCUP database in which a smoking ban was not implemented during the study period; and second, the entire country. If the entire country does not qualify as a comparison group, then I don't know what does.

Look - I am not claiming that this analysis is perfect or even that it suggests that smoking bans do not have a significant effect on heart attacks. My only point is that I think it is simply premature to be publicly claiming that smoking bans will produce a 27%-40% reduction in heart attack admissions. That's it.

Most importantly, I think I am bringing to light an important issue that deserves careful attention and further scientific analysis. I think that it deserves consideration. But attacking and insulting the person who makes such a suggestion without even attempting to read the entire piece or to discuss the scientific issues intelligently is just not appropriate.

And what it suggests to me, honestly, is that there is something missing. And what I think is missing is a sincere interest in discussing the science and in considering the different possibilities for what might explain the observed findings in the existing literature. This is precisely why it suggests to me that for some in the anti-smoking movement, the agenda seems to be driving the interpretation of the science rather than the science driving the agenda.

This has been a true learning experience for me. Never did I dream that some day, after 21 years of experience in tobacco policy research, as a statistical editor of perhaps the top tobacco control journal, and with over 50 peer-reviewed publications in top public health and medical journals, I would present a reasonably detailed scientific analysis of a tobacco control policy issue and then be publicly attacked and insulted for having the courage to present my opinions.

But because they apparently go against the anti-smoking agenda, I have now been publicly attacked and insulted. That's a shame.

But what's even more of a shame is that this issue really has nothing to do with the anti-smoking agenda. The issue of smoking bans should be decided based on the evidence regarding the health effects of secondhand smoke on bar and restaurant workers. It really doesn't matter, in my mind, whether smoking bans reduce heart attacks or not. The justification for such bans does not rest on such a determination. What does seem to depend on it, however, is the political ammunition that some anti-smoking groups and advocates seem to desire.

Finally, there are a lot of people who have expressed their scientific opinions on issues in tobacco control who I disagree with. But I would never attack and insult any of them, privately or publicly, for expressing their views. I think there has got to be a better way to practice public health and tobacco control.

New Study Casts Doubt on Claim that Smoking Bans Substantially Reduce Heart Attack Admissions

A new study released yesterday on the Smoker's Club, Inc. web site, questions the claim that smoking bans cause a 40% (as observed in Helena, Montana) or 27% (as observed in Pueblo, Colorado) drop in hospital admissions for myocardial infarctions (heart attacks).

The authors, David W. Kuneman and Michael J. McFadden, analyzed data on hospital admissions for acute myocardial infarction from the HCUP project (Healthcare Cost and Utilization Project), which is "a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership and sponsored by the Agency for Healthcare Research and Quality. HCUP is based on statewide data collected by individual data organizations across the United States and provided to AHRQ through the HCUP partnership. ... HCUP data are used for research on hospital utilization, access, charges, quality and outcomes. ... Researchers and policymakers use HCUP data to identify, track, analyze and compare hospital statistics at the national, regional and State levels."

Specifically, the authors examined the total number of hospital admissions for acute myocardial infarction in the year prior to and after a smoking ban in each of four states which enacted some form of smoking ban in restaurants and/or bars during the period for which data from HCUP are available (1997-2003): California, New York, Florida, and Oregon.

For California, a complete ban on smoking in bars was implemented in January 1998. Heart attack admissions increased from 40,608 in the year preceding the bar smoking ban (1997) to 43,044 during the year following the smoking ban (1998), an increase of 6.0%.

For New York, a complete ban on smoking in bars and restaurants was implemented in July 2003. Heart attack admissions increased from 31,728 in the year preceding the bar smoking ban (2002) to 31,888 during the year in which the smoking ban was implemented (2003), an increase of 0.4%.

For Florida, a ban on smoking in restaurants (free-standing bars excluded) was implemented in July 2003. Heart attack admissions decreased from 40,077 in the year preceding the bar smoking ban (2002) to 39,783 during the year in which the smoking ban was implemented (2003), a decrease of 0.7%.

For Oregon, a ban on smoking in restaurants which allow children was implemented in July 2001. Heart attack admissions increased from 4,957 in the year preceding the ban (2000) to 5,125 in the year following the ban (2002), an increase of 0.4%, and there was almost no change in heart attack admissions during 2001 -- the year in which the ban was implemented (4,927, 0.1% decrease from 2000).

The authors point out that none of these findings provides any suggestion that the statewide smoking bans had any immediate and substantial effect on heart attack admissions.

The authors point out that while the total number of heart attacks studied in Helena and Pueblo totaled 315, the total number of heart attacks in this study was over 315,000, or 1,000 times higher. They suggest that this larger sample size as well as the examination of state-wide data rather than just data in isolated cities makes the conclusions from this study more stable than from the existing studies on this topic.

The paper concludes: "Statistically this larger population base makes for a far more stable statistical environment and the data from this population would provide a far sounder scientific basis for decisions about smoking bans that will affect the lives and livelihoods of millions of people."

The Rest of the Story

In addition to confirming Kuneman and McFadden's findings, I extended their analysis by:
  • examining trends going back in time as far as 1997, the earliest available online data (in order to have a more stable baseline period to establish secular patterns); and
  • examining trends in heart attack admissions in all the other states in the online database without smoking bans that included data for the entire study period 1997-2003 (a total of 8 states - New Jersey, South Carolina, Utah, Washington, Arizona, Colorado, Hawaii, and Iowa; Massachusetts was not included because of the extensive local smoking bans) (in order to have a comparison group).
For California, I compared heart attack admission trends during the period 1997-2002 for California versus the 8 non-ban states in the HCUP online database and versus the nation as a whole. Trend lines were essentially parallel throughout the period. From 1997 to 1998, heart attack admissions in California increased by 6.0%, compared to a 3.8% increase in the comparison states and a 6.2% increase in the remainder of the nation. From 1997 to 1999, heart attack admissions increased by 9.9% in California, compared to 4.8% in the comparison states and 4.3% in the remainder of the nation.

For New York, overall trends were similar to those in the comparison states and to the nation as a whole, except that New York did not experience the slight decline in heart attack admissions during 2003 that was observed elsewhere. In New York, admissions for heart attacks increased by 0.4% from 2002 to 2003, while heart attacks decreased by 3.1% in the comparison states and by 2.8% nationally during the same time period.

For Florida, heart attack admissions increased slightly faster than in the comparison states between 1997 and 2000, but the patterns were similar from 2000-2003. There was a slight decrease in heart attacks between 2002 and 2003 in Florida (0.7%), the comparison states (3.1%), and the nation as a whole (2.8%).

For Oregon, there was a 0.4% increase in heart attack admissions from 2000 to 2002, while admissions in the comparison states dropped by 0.7% during the same period, and admissions nationally increased by 4.3%.

Commentary and Conclusions

I think Kuneman and McFadden are to be congratulated for having made an important contribution to the analysis of this research question. I think that their analysis, along with my extension of that analysis, provides compelling evidence that brings into question the conclusion that smoking bans have an immediate and drastic effect on heart attack incidence.

In fact, these analyses demonstrate that on a state-wide level, there is no suggestion of any large-scale effect on heart attack admissions associated with the implementation of statewide bans on smoking in child-friendly restaurants, all restaurants, bars, or bars and restaurants.

If there were a true 27% or 40% decrease in heart attack admissions due to smoking bans that occurred almost immediately (within six months, as claimed), one would have expected to see a demonstrable decline in such admissions in states that implemented such bans.

An effect of such smoking bans can certainly not be ruled out, especially because the 2004 data for New York and Florida are not yet available (so only the first six months post-ban could be examined). However, it does seem quite clear that if there is an effect, it is not nearly as immediate or as dramatic as suggested in press releases. (see also Pueblo release and Bowling Green press release and Greeley news article)

My honest appraisal of what is going on here is that anti-smoking groups have been too quick to go to the media with definitive claims of a drastic and immediate effect of smoking bans on heart attacks when the scientific evidence is simply not sufficient to support such claims. What is happening, I believe, is that the anti-smoking agenda is driving the interpretation of the science. As I stated before, it is an agenda which, in this case, I wholeheartedly support (I have been lobbying for workplace smoking bans, especially those in bars and restaurants for 21 years). However, I don't think the importance of the ultimate objective justifies the use of shoddy science to support that objective.

At this point, I must make 3 critical points:

First, I am not suggesting that there was anything wrong with the studies that were done in Helena and Pueblo or that the authors did anything wrong in stating their conclusions within the Helena paper. What I am suggesting, instead, is that drawing definitive, generalized conclusions based on these two small studies, and sending out press releases to the media with these definitive conclusions (before the Pueblo study has even been published) is irresponsible and undermines the scientific credibility of the tobacco control movement.

Within themselves, it may be that the Helena and Pueblo studies are quite solid (I have argued not with respect to the Pueblo study, but there is room for differing interpretations of the evidence); however, that doesn't mean that the evidence is sufficient to support a general conclusion that smoking bans reduce heart attacks by 27-40%. The fact that population-wide studies with much larger sample sizes do not seem to bear out these findings is exactly the reason why one has to be careful in concluding an effect with a small and select sample (and especially, in the face of huge random variations in secular trends in a small geographical area).

Second, I am not suggesting that this is a reason not to support smoke-free restaurant and bar laws. In fact, one of the things that I think tobacco control groups have been doing wrong is using data such as this to support such ordinances. I think the reason for these laws is that secondhand smoke is a substantial workplace hazard for bar and restaurant workers. That's it. Whether the laws end up reducing heart attacks (probably by virtue of smokers quitting or cutting down) or not is not relevant in my mind to the issue of whether we should protect workers from a substantial and preventable occupational hazard.

I think by harping on these data, anti-smoking groups have set themselves up for failure, and therefore done a disservice to the overall effort to protect workers from secondhand smoke. Because now that valid scientific doubt is being cast on this exaggerated claim, it may well hurt the effort to protect these workers.

This is what I meant when I suggested that the credibility of the movement is being threatened by the tactics being used. If the focus of the debate shifts to the validity of the heart attack reduction claim rather than the need to protect workers from a severe and preventable occupational hazard, then we may well lose the debate. I fear this is now going to happen now that the "cat is out of the bag."

Third, and finally, I am not concluding here that smoking bans do not reduce heart attacks. I am not even concluding that smoking bans did not reduce heart attacks in Helena or Pueblo. What I am concluding is that the overall evidence does not support the conclusion that the observed declines in heart attack admissions in Helena or Pueblo (or Bowling Green or Greeley) are in fact: (1) real, rather than simply chance variations; (2) attributable to the smoking ban, rather than some other factor; and (3) widely generalizable to other communities.

It is possible, for example, that local smoking bans may have an effect that state-wide smoking bans do not have. Perhaps all the local media attention focuses public attention on the matter and results in publicity that ends up changing smoking behavior. And perhaps that doesn't happen as effectively at a state level. But I think a lot more research is needed before we can conclude that the reason why we don't observe a substantial reduction in heart attack admissions associated with smoking bans on a state-level is that the effect only holds at a local level.

Moreover, I would point out that in my analysis of trends in heart attacks in Massachusetts, where there was a huge proliferation of smoke-free bar and restaurant regulations between 2000 and 2003, I found that heart attack admissions increased in Massachusetts by 31.8% during this time period, compared to a 2.4% decline in the comparison states, and a 1.5% increase nationally.

In short, what I am concluding is that it is far too premature to conclude that smoking bans reduce heart attacks substantially and in a short period of time. And that as much as anti-smoking groups are doing important work by promoting smoke-free bar and restaurant laws, it simply is not responsible (nor wise strategically, I think) to be using shoddy science to support this cause. In the long run, it is our credibility (and ultimately therefore, the health of the public) that is going to lose out.

Tuesday, November 29, 2005

Update on Double Challenge to Campaign for Tobacco-Free Kids and Ignite

On November 15, I issued a double challenge to the Campaign for Tobacco-Free Kids and Ignite to call for strengthening of the proposed FDA tobacco legislation. Since both organizations appear to be strongly opposed to special protections for Big Tobacco and the currently proposed FDA legislation is full of such special protections, I think that if these organizations really are sincere in what they are saying publicly, that they will call for the strengthening of this legislation to remove these special protections.

So far, in response to my challenge, neither organization seems to have stepped up to the plate. I'll continue to monitor the situation, and report back to my readers if either or both of these organizations wins the challenge and stops speaking out of both sides of their mouths.

Monday, November 28, 2005

It's Not All or Nothing: Renouncing Some, But Not All, of the Anti-Smoking Agenda and Tactics

It has come to my attention that a number of people are having trouble placing me upon the overall stage of the tobacco control movement.

On the one hand, some anti-smoking advocates appear to be taking my criticism of some of the agenda and many of the tactics of the tobacco control movement lightly, and to assume that I simply have "grudges" with certain anti-smoking groups and am not really renouncing any of the agenda or tactics, but just using these issues to try to take out these "grudges."

On the other hand, some anti-smoking advocates appear to be taking my criticism too heavily, and to assume that I am renouncing the entire anti-smoking agenda and all of its tactics.

The Rest of the Story

Actually, neither of these impressions is accurate.

One of the dogmatic axioms of the anti-smoking movement that I've recently learned is that the agenda and the tactics basically come in an all-or-nothing package. There's almost a religious element to it, almost an orthodoxy, by which you cannot really as an individual choose to honor some specific elements of the agenda and of the tactics. If you criticize any, you are accused of being a heretic or a naysayer (or even worse, of being a tobacco industry supporter).

So no - I have not rejected the entire anti-smoking agenda and all of its tactics. At the same time, I am very serious in the criticisms that I have made.

Ironically, the two groups/individuals who seem to be able to place me perfectly are outside of the tobacco control movement.

First, FORCES International seems to really understand where I am coming from. In featuring a number of my commentaries over the past months, FORCES has always shown an accurate understanding of who I am. They continue to describe me as a tobacco control advocate and they seem to understand that just because I have opened my eyes to what I see as some inconsistencies and unethical tactics in the movement, that doesn't mean that I'm not a part of that movement or that I have rejected it all.

Second, in highlighting a number of my posts, Jacob Sullum, in Reason Online's Hit & Run blog, has also got me pegged quite accurately. While acknowledging some areas where I have expressed dissent with the dogma of the movement, he also describes me as being "determinedly anti-tobacco," demonstrating that he understands exactly where I am coming from as well.

In fact, I continue to support and work for much of the tobacco control agenda, including efforts to protect nonsmoking workers from secondhand smoke in the workplace, something I have been working for during the past 21 years, as well as strong statewide tobacco control programs with effective media campaigns. What I renounce, however, are what I see as policies that have gone beyond the realm of public health - such as those which discriminate against smokers in employment, tax smokers to balance budgets in a politically comfortable way, and ban smoking in open, non-enclosed outdoors areas where people can move about freely.

And more importantly than the agenda, I renounce many of the tactics being used by tobacco control groups. I don't think it's acceptable to be dishonest, deceptive, or not to be forthright. I do think it's important to have integrity, sincerity, and consistency in one's positions. I don't think it's OK to issue personal attacks against individuals, especially when they are not supported by appropriate documentation. I don't think it's OK to imply false information about groups, even if they are on the opposite side of the fence on the issues we are working for. And I don't think it's appropriate to allow the agenda to dictate our interpretation of the science.

I think it's important for people to understand that it is not all or nothing. I think one can look at the current agenda and current tactics of the tobacco control movement and based on 21 years of experience in the movement, come to an opinion that some of that agenda and some of those tactics are inappropriate. And I don't think that means you are just expressing a "grudge" or that you are renouncing the entire tobacco control movement and packing your bags to start working for the tobacco companies.

A number of people have asked me whether I think there is anything tobacco control is doing right. Of course I do. If I didn't, I would have completely renounced the entire movement. I think much of what the individual tobacco control advocates are doing is right, but unfortunately, I see the movement as having been largely co-opted by a few large national organizations that are exceedingly well-funded (compared to the advocates), and those organizations are basically charting the course.

Although I believe the overwhelming majority of advocates are doing the right thing or want to do the right thing, I'm afraid that when the leadership of a movement becomes tainted and starts to pursue an errant agenda and to use unethical or inappropriate tactics to do so, it reflects upon the whole movement. It's kind of like a large company where the CEO or management does some sketchy things. That doesn't mean that everyone who works at the company is doing anything wrong, but it's impossible for the actions of the leadership of the company not to reflect poorly on the company itself.

And so, it's precisely because I think there is so much worth saving in the tobacco control movement that I have chosen to speak out, to create this blog, and to use this blog as a forum to try to spark some change in the tobacco control movement.

Dissent Not Allowed: Criticizing Tobacco Control Groups is a Display of Lack of Discipline

I received an interesting response to my post expressing disappointment with being personally attacked by anti-smoking groups or advocates for taking a position in opposition to policies that discriminate against smokers in the workplace and in opposition to policies that ban smoking broadly in open, non-enclosed outdoors areas where people can move about freely.

One anti-smoking advocate wrote:

"I am quite certain that the tobacco industry law firms all have a copy of this undisciplined rant from Michael Siegel and plan to use this and other quotes from his article to telling effect in all future political and legal actions."

The Rest of the Story

What I find most interesting about this response is not my blog being called a "rant" (I'm still a pretty good sport about this kind of denigration), but the use of the word "undisciplined."

Apparently, what is troublesome is not the serious problems I have pointed out with the tactics being used in the anti-smoking movement, but instead, the fact that I have lacked the discipline to restrain myself from speaking out.

Apparently, I am supposed to be highly disciplined as a tobacco control advocate, and part of that discipline is, I guess, not sharing my criticisms or dissent with the actions taken by tobacco control organizations, for fear that my criticism may then be used by tobacco company lawyers against us.

I would have felt a whole lot better if the discipline that this advocate was looking for was discipline in crafting careful, well-documented arguments. Had this advocate taken specific issue with any (even one) specific point I made in my posts, or in the documentation or argumentation that I provided to support my points, that would have been wonderful. But instead, the point was simply that I should have had the discipline to muzzle myself.

I call it like I see it and I speak out when I believe that something we're doing (or the way we're doing it) is wrong.

The rest of the story suggests that I guess I simply have to admit that I lack discipline as a tobacco control advocate: I just don't have the ability (or desire) to muzzle myself whenever I disagree with a policy that is being advocated or in the way that policy is being promoted.

Saturday, November 26, 2005

Campaign for Tobacco-Free Kids' Hypocrisy Exposed Yet Again: This Time in Opposition to (and Support of) $1.50 Cigarette Tax Increase

According to two recent newspaper articles (1 2), the Campaign for Tobacco-Free Kids (TFK) is supporting a California ballot initiative to increase the state's cigarette tax by $1.50 per pack to fund health and anti-smoking programs and is opposing a California ballot initiative to increase the state's cigarette tax by $1.50 per pack to fund health and anti-smoking programs.

No -- you are reading that correctly, it's not a typographical error. TFK is listed as both a supporter of the Tobacco Tax, Disease Prevention and Children's Health Insurance Act and as an opponent of the Emergency Services and Tobacco Tax Act.

Each would increase the state cigarette tax by $1.50 per pack primarily to fund health-related government programs: the former would primarily support health insurance coverage for children and the latter would primarily support hospital emergency care services. The former allocates 9% for smoking prevention while the latter allocates 21% for tobacco prevention and control.

to TFK: "Increasing cigarette taxes is a WIN, WIN, WIN solution for states - a health win that reduces smoking and saves lives; a fiscal win that raises revenue and reduces health care costs; and a political win that is popular with the public." It is quite clear that TFK has waged a campaign to increase state cigarette taxes, simply because the tax increase itself is an intervention that TFK supports. It is quite clear that the purpose to which the revenues are allocated is not critical to TFK's support for this policy intervention.

In fact, TFK's fact sheet implies support for cigarette taxation as a means to balance state budgets: "To balance state budgets, voters strongly prefer increasing state tobacco taxes over either other tax increases or cuts to vital state programs."

The Rest of the Story

I find the campaign for Tobacco-Free Kids' opposition to the Emergency Services and Tobacco Tax Act to be inconsistent with its expressed opinions about tobacco taxes and its campaign to increase these taxes, and I find its opposition to this Act to be highly hypocritical.

If cigarette taxes are a "WIN, WIN, WIN" solution because they reduce smoking and save lives while at the same time raising revenue and reducing health care costs, and all in a way that is popular with the public, then the Emergency Services and Tobacco Tax Act should be something that TFK supports.

Why is TFK taking the tobacco industry's side on this measure and opposing something that is clearly designed to help the children? After all, kids are the most price sensitive and this increase in the cigarette tax will, as TFK loves to say, save lives by reducing smoking among kids. It will help prevent yet another generation of kids from becoming addicted to cigarettes.

After all: "Studies, and experience in state after state, show that higher cigarette taxes are one of the most effective ways to reduce smoking among both youth and adults. Every 10 percent increase in the price of cigarettes will reduce youth smoking by about seven percent and overall cigarette consumption by about four percent."

Not only that, but the Emergency Services and Tobacco Tax Act will raise much-needed revenue to help support emergency medical care. What could be more important than emergency medical care?

And on top of all of this, the reduction in smoking will substantially reduce health care costs for the state and to boot, the public supports cigarette tax increases: "Polls conducted in numerous, diverse states throughout the country have consistently shown broad public and voter support for cigarette-tax increases." Moreover, "to balance state budgets, voters strongly prefer increasing state tobacco taxes over either other tax increases or cuts to vital state programs."

I think that TFK's opposition to the Emergency Services and Tobacco Tax Act brings into question the sincerity of its justification for tobacco tax increases. If they mean what they are saying, then supporting this ballot initiative should be a no-brainer.

The opposition of other health groups - such as the California Medical Association - to the Emergency Services ballot measure also brings their sincerity into question, I believe, but at least these groups do not have a long-documented history of campaigning for cigarette tax increases and of justifying these tax increases based simply on the fact that they will reduce cigarette consumption and save lives, with state revenue generation as an additional benefit.

Given the propaganda about cigarette taxes that TFK has put out, it is completely inconsistent with its position to oppose the $1.50 per pack cigarette tax ballot initiative in California to fund emergency health services and it is extremely hypocritical of TFK to oppose this initiative, while at the same time supporting similar initiatives in states throughout the country.

The rest of the story suggests, to me, that there simply is a lack of integrity in the leadership of the tobacco control movement. They say one thing, but do another. How can they expect to have any credibility or to be viewed as being sincere when they basically ignore months and months of propaganda they have themselves put out? You simply can't have it both ways.

Health Groups' Knee-Jerk Support for Cigarette Taxes Starting to Backfire: Re-Thinking of Cigarette Taxation as a Tobacco Control Strategy is Needed

One of the basic rules I was taught as a tobacco control advocate was that increased cigarette taxes were a good public health policy because they save lives by reducing cigarette consumption. In general, each 10% increase in the price of cigarettes results in about a 4% decline in cigarette consumption.

Recently, however, an unforeseen problem has arisen - one which leads me to question whether health groups' knee-jerk support for cigarette taxes might not be backfiring: namely, the use of cigarette taxes to fund essential government programs has made the government dependent upon cigarette tax revenue and has therefore removed any incentive for policy makers to enact policies that might reduce cigarette consumption.

An article in today's Trenton Times explains that state legislators in New Jersey are considering opposing a state smoke-free workplace law on the grounds that it would decrease cigarette consumption and therefore threaten to reduce cigarette tax revenues and the programs funded by these revenues.

According to the article, David Rousseau, a deputy state treasurer, "said a ban that cuts consumption might force the state to provide updates to bondholders who receive debt payments from the state that are funded by the cigarette tax. ... Most money earned from the cigarette tax is used to help balance the annual budget."

The article explains that: "The debate about banning indoor smoking in public places has focused on making the air healthier, but state fiscal officials wonder if such a ban might also bring about an unintended consequence - slamming state revenues. The state government hopes to get $626 million this fiscal year from its cigarette tax, an amount that makes it the third most important tax revenue source for the state budget, behind only sales and corporate business taxes."

At the same time, a ballot initiative to increase the cigarette tax in California by $1.50 per pack to fund smoking prevention and smoking cessation programs as well as disease treatment is severely threatened because another ballot initiative being promoted at the same time proposes to increase the cigarette tax by $1.50 per pack to provide more money to hospitals.

It is perhaps the precedent that health groups have set by supporting the use of cigarette tax increases to fund government services that has opened the door for the California Hospital Association to propose using the state's cigarette tax as a method of solving hospitals' fiscal woes.

It may well be that the presence of the competing cigarette tax initiatives in California may kill the health groups' measure because it is perhaps unlikely that voters would support two consecutive huge increases in cigarette taxes within a six-month period: "Supporters of the health group bill also recognize voters might be reluctant to back an additional cigarette tax in November if they approve one in June."

Some health groups now find themselves in the difficult position of having to oppose one cigarette tax increase but to support another one, and they are having trouble presenting a rational justification for this position.

According to the San Francisco Chronicle article, the Campaign for Tobacco-Free Kids is one group that is opposing the first (i.e., the California Hospital Association-supported), but supporting the second proposal to increase the state cigarette tax by $1.50 per pack. Yet this is inconsistent with its public campaign to support cigarette tax increases: "Increasing cigarette taxes is a WIN, WIN, WIN solution for states - a health win that reduces smoking and saves lives; a fiscal win that raises revenue and reduces health care costs; and a political win that is popular with the public."

The emerging inconsistency in the anti-smoking groups' support for these cigarette tax measures is, I think, going to hurt the cause because the hypocrisy of the health groups' position is going to become readily apparent to the public.

The Rest of the Story

I think there are two lessons from this story.

First, there are some serious consequences to the use of cigarette tax revenue to fund government programs and services that should lead anti-smoking groups to question their support for these taxes in all but a few special situations (namely: those in which a substantial portion of the revenue will be used to fund smoking prevention and cessation programs and to provide direct benefit to smokers, such as providing support and medical care).

The most serious consequence is the government's dependence on cigarette consumption to fund essential programs and services. While in the short-run, the decrease in cigarette consumption due to the tax increase may be beneficial to the public's health, I think that in the long-run, the creation of an inherent incentive for the government not to enact policies that will reduce cigarette consumption in the future may be a far greater effect that will more than negate the positive public health benefit of the initial tax increase.

Second, the anti-smoking groups' knee-jerk support for cigarette tax increases has now exposed the glaring lack of justification for this support. Because now, the same groups are opposing a cigarette tax increase by other health groups. The in-fighting between the health groups is going to have a negative impact on the public perception of the use of cigarette taxes to fund government programs. And the apparent abrupt change in position of groups like the Campaign for Tobacco-Free Kids is going to make the public question the soundness of the reasoning of these groups in supporting cigarette tax increases.

From a public perspective, the credibility, sincerity, and motivation of the health groups is called into question by newspaper articles such as the one which states: "Health advocates have long supported the idea of increasing taxes on tobacco products, both to discourage consumption and to help pay for health care services" and which then goes on to explain that "several groups, including the California Medical Association, the California Nurses Association, Health Access California and the Campaign for Tobacco-Free Kids, have come out against the hospital-backed proposal."

Had the health groups like the Campaign for Tobacco-Free Kids not been so eager to tax cigarettes for any purpose under the sun, I don't think they would be in the predicament that they face today. Because by being more careful to justify the specific need for the cigarette tax increases in the past, they would have been able to explain in a rational way why one of these proposals is a good one and one is a bad one.

But when you are on record as stating that any cigarette tax increase is a "win, win, win" proposal, you aren't going to look too consistent arguing that in fact, a $1.50 per pack cigarette tax increase is a win proposal while another $1.50 per pack cigarette tax increase is a lose proposal. Instead, you appear to the public, I think, like a group that simply wants to get a piece of the pot.

Wednesday, November 23, 2005

Nicotine Replacement Therapy Success May Largely Be Due to Placebo Effect; Research Questions Pharmacotherapy as Basis for National Cessation Plan

It may be that double-blinded, placebo-controlled trials of nicotine replacement therapy (NRT) products for smoking cessation are not as blinded as we previously thought. And that the blindness failure may bring into question the validity of NRT clinical trial results as well as the wisdom of heavy reliance on pharmacotherapy in the national smoking cessation action plan that was recently developed and played a large role in the proposed DOJ tobacco lawsuit remedies.

Two recent studies have examined the possibility that clinical trials of NRT may not be truly blinded and that the blindness failure may actually result in a bias toward finding a significant effect of NRT on smoking cessation when a true effect may not exist.

First, a 2004 study in Addictive Behaviors found that relatively few (17 of 73 studied) NRT trials have even made an attempt to assess the blinding success of their studies. And of the few which did, more than half found a blindness failure. Only 3 of these studies attempted to determine whether blindness bias was present (see: Mooney M, White T, Hatsukami D. The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials. Addictive Behaviors 2004; 29:673–684).

According to the study authors: "The NRT literature has been largely silent on the topic of blindness failure ... Based on the relatively few identified studies, definitive conclusions about the frequency and consequences of blindness failure are not justified. To determine the prevalence of failure, clinical trials of NRT should uniformly test the integrity of study blinds. Moreover, if blindness failure is observed, subsequent efforts should be made to determine if blindness failure is related to study outcome and, if so, to provide an estimate of treatment outcome adjusted for blindness bias. Without these methods and analyses, the validity of NRT clinical trial results could be questioned."

Note that since the methods and analyses being suggested by the authors have generally not been used in the existing literature, the inference is that the authors are questioning the validity of current NRT clinical trial results.

Second, a 2005 study in the Journal of Consulting and Clinical Psychology actually re-analyzed the results of an earlier study of the effectiveness of NRT therapy in reducing cigarette consumption. The authors found that blindness failure occurred. Of those subjects who received nicotine, 38.5% guessed that they were receiving nicotine, but 26.3% guessed that they were actually receiving placebo. Of the subjects who received placebo, 16.4% actually thought that they had received nicotine (see: Dar R, Stronguin F, Etter J-F. Assigned versus perceived placebo effects in nicotine replacement therapy for smoking reduction in Swiss smokers. Journal of Consulting and Clinical Psychology 2005; 73:350-353).

More importantly, the authors found that perceived drug group assignment was strongly related to smoking reduction in the study. In fact, the relationship between perceiving that a subject was getting nicotine and successful smoking reduction was so strong that this effect completely explained the original study's finding of a significant effect of NRT therapy in reducing cigarette consumption.

The authors concluded that "reduction of smoking was strongly related to participants' beliefs about their drug assignment. Smoking reduction was larger in those who believed that they had received nicotine compared with those who believed they had received placebo, regardless of actual drug assignment. Moreover, after adjustment to perceived drug assignment, the association between actual drug assignment and smoking reduction was no longer statistically significant."

The Rest of the Story

Essentially, what these studies are suggesting is that because nicotine is a psychoactive drug, it is quite possible that smokers may be able to distinguish between nicotine and placebo quite quickly, and this ability to distinguish the two is far greater than by chance. This phenomenon is called blindness failure.

Next, these studies suggest that the blindness failure may be introducing a bias into the study. It is possible that smokers' judgments about whether they have received nicotine or placebo may be related to the study outcomes: namely, smoking cessation or reduction in cigarette consumption. The more recent study found this to be the case, and the effect was large enough to explain the entire observed positive effect of NRT therapy in that study. This effect is called blindness bias.

Next, the studies suggest that because of the likely presence of blindness bias in this type of research, analytic methods must be used to adjust for this blindness bias. This is called bias adjustment. In the case of the Dar et al. study, this adjustment actually negated the observed effects of NRT in the original study.

Finally, these studies imply that because the current literature on the effect of NRT therapy does not adequately examine blindness failure, determine whether blindness bias occurred, and conduct bias adjustment in reporting the results, the validity of the existing NRT clinical trial results is subject to question.

I think it is important to point out that if it is true that blindness bias explains some of the observed effect of NRT products, this doesn't mean that the use of the products does not improve smoking cessation. It just implies that the reason for the effectiveness of the therapy may not be the nicotine itself, but rather, the belief that the subject is receiving something that will help them. In other words, it would imply that the observed effect is essentially a placebo effect.

For example, this would mean that giving someone a placebo but telling them it is nicotine would be as effective as giving someone nicotine. And for the proportion of subjects who receive nicotine but think it is placebo (26% in the above study), they would be expected to fare worse than subjects who are given placebo but told it was nicotine (I'm not suggesting lying to patients as an intervention - I'm just using this example to illustrate and explain this point).

I think the rest of the story casts some doubt on the heavy reliance upon pharmacotherapy in the proposed national smoking cessation action plan. I think it's entirely possible that the putative effects of NRT therapy, if applied on a national level, have been considerably exaggerated and that the ability of the proposed smoking cessation plan to cause five million Americans to quit within one year, as claimed, may be overstated.

I do think it is important for readers to know that the chair of the committee that prepared the smoking cessation action plan has a rather large conflict of interest in making pharmacotherapy the cornerstone of the plan because he "has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Pharmacia, Pfizer, and Sanofi-Synthelabo" and in 1998, he was named to a university chairmanship made possible by an unrestricted gift to his university from GlaxoWellcome. He has also received funding from the Robert Wood Johnson Foundation."

With that said, I should disclose my own conflict of interest in writing this post: I have received funding in the past from the Robert Wood Johnson Foundation and own some Pfizer stock. Of course, it should be noted that there probably is not a true conflict of interest here as it would, if anything, bias me towards overstating the potential role of pharmaceutical products, not challenge the existing belief that these products should form the cornerstone for a national smoking cessation action plan.

My own feeling, based on my years of experience in tobacco control, is that pharmacotherapy in general is over-emphasized and that most smokers who quit successfully long-term are those who quit cold turkey without any particular pharmaceutical aids. It is also important to note that smokers who relapse after having tried NRT therapy tend to do dismally in future cessation attempts with NRT. All in all, I think that the benefits and importance of drugs in the smoking cessation process have been over-emphasized, and I urge readers to read extensively on the web site of John Polito, who I find has the most insightful understanding of the smoking cessation process and the potential role of NRT products as anyone I know in the tobacco control field.

Ventura Poised to Ban Smoking in All Parks and Beaches

The Ventura (California) City Council Monday night agreed to move forward with drafting an ordinance that would ban outdoors smoking in all city parks, on all city beaches, and in the city Promenade and city plaza. City officials admitted that this was mainly a "feel-good" ordinance and that enforcement would not be a priority, if it would exist at all:

"Councilman Carl Morehouse, whose sister passed away from lung cancer, said he was concerned about having an already stretched police force having to enforce what he called a 'feel-good law,' but said he felt it was important to move forward with the restrictions. The city staff emphasized police enforcement would not be a priority."

The measure is not as draconian as it may sound, however, as one councilmember wants the ordinance to exempt the city's two golf courses. Her reasoning in support of the ordinance: "Basically, the question to me is does smoking in parks do more harm than good? The answer is yes, and we need to stop it."

The Rest of the Story

First, I find it interesting that smoking on golf courses does more good than harm, but that smoking in parks, beaches and plazas and promenades does more harm than good. What kind of ludicrous reasoning is this?

But I think it demonstrates just how poor the justification is for these types of laws. The inconsistency in the justification is blatant. If smoking is so bad that it needs to be banned in parks and beaches, plazas and promenades, then it certainly would need to be banned on golf courses as well. If people need to be protected from any possible exposure from secondhand smoke, then there is absolutely no justification for the Ventura City Council allowing smoking on the city's golf courses.

More importantly, the entire nature of the discussion seems to reveal how poor the justification for these types of laws is. The council is basically admitting that this is largely a "feel-good" ordinance that will not be enforced. The police department has indicated that it has no interest in enforcing the law.

This could well backfire and set back efforts to protect people from secondhand smoke. Because if smokers start to violate the law outdoors and their violations are essentially ignored, it will undermine the enforcement of smoking violations indoors. Once society condones and overlooks people ignoring smoking laws, then it sets a precedent for all smoking laws to be overlooked.

The reason why the nature of the discussion over this policy appears to be so weakly related to public health, I think, is that no one can provide solid evidence that exposure to secondhand smoke in open outdoors places where people can move freely, like parks and beaches, plazas and promenades, is a substantial public health hazard that is causing significant health problems or diseases.

Thus, they have to fall back on weaker justifications, such as emphasizing the litter problem, the nuisance, or the desire to protect children from seeing smokers.

But these types of justifications I think undermine the entire clean indoor air movement (which I see as legitimate). Because when the focus comes off of harm done to nonsmokers and on to nuisances, litter, and social engineering, I think we lose (and should lose).

Anti-smoking groups which included the American Cancer Society and the American Lung Association are apparently supporting this ordinance. I would suggest that they are hurting the overall cause of protecting people from secondhand smoke by doing so. Because once we start supporting measures for which we cannot provide solid scientific evidence to back up our claims (that the measure is an intrusion that is necessary to prevent a substantial public health problem), then our ability to effectively promote measures for which we can actually document a serious public health threat is going to be compromised.

Tuesday, November 22, 2005

More Dangers of Supporting Increased Cigarette Taxes to Fund Government Programs Revealed

According to an Associated Press story, Hollywood director Rob Reiner has threatened to oppose a ballot initiative that would increase the state's cigarette tax because it would reduce cigarette consumption, and therefore decrease cigarette tax revenue that is allocated to a pre-school education program that he championed in a 1998 ballot initiative:

"Hollywood director Rob Reiner warned the California Hospital Association Friday to withdraw or rewrite a ballot proposal it's pushing for 2006, saying it threatens to snatch up to $34 million a year from needy preschoolers. Reiner, a longtime activist, championed a 1998 ballot proposal slapping a 50-cents-a-pack tax on cigarettes to fund health and education programs for children up to 5 years old, now known as First 5 California. In his letter, Reiner argued the hospital proposal, which calls for a $1.50 tax on each pack of cigarettes to fund emergency rooms and other health programs, would slash First 5 funding. If the state increased cigarette taxes as proposed by the hospitals, purchases would inevitably decline as smokers shop elsewhere for lower prices or give up the habit. If fewer cigarettes are sold in the state, tax collections will decline. In turn, First 5 would receive less money."

"Reiner, who finds himself in the awkward position of arguing against a tax increase that could decrease smoking, pegged the loss at $34 million. 'We all share the goal of reducing the harmful effects of smoking and improving access to health care,' Reiner wrote. But 'an initiative which cuts funding for children's health and early education is bad for California.'"

The Rest of the Story

This story reveals one of the problems with creating a government dependence on tobacco revenues to fund needed and valuable public programs. It removes the incentive to take any government action to reduce tobacco use because such a reduction would decrease cigarette tax revenues and therefore threaten these public programs.

Here, we have the absurd and ironic reality of Rob Reiner arguing that an initiative that would reduce cigarette consumption is bad for California because it would cut funding for children's health and early education.

The fact that the cigarette tax was increased in 1998 to pay for early childhood education is now a major obstacle in the way of government adoption of a policy to reduce cigarette use. The incentive not to threaten funding of government programs is so strong that even a supposed crusader for public health is arguing against such a policy.

This story is an illustration of why tobacco control advocates and groups should be hesitant to support every proposed cigarette tax under the sun. It is not, as the Campaign for Tobacco-Free Kids has suggested, a win-win-win situation. In fact, it may well be a lose situation because by increasing government dependence on tobacco revenues, it removes any incentive for government action to reduce tobacco consumption.

This story also illustrates the folly of the proposal by Physicians for a Smoke-Free Canada for the government to buy out the tobacco companies and transfer them to a non-profit entity. The proposal would create a huge financial dependence of the government on tobacco revenue and would remove any incentive for policies to reduce tobacco consumption.

The rest of the story suggests that the rabid enthusiasm of anti-smoking groups for any and all cigarette tax hikes is irresponsible public policy. It may look good in the short-term, but in the long-run, it is going to come back to haunt us.

FORCES International Accused of Being a Tobacco Industry Tool

My post on the Americans for Nonsmokers' Rights (ANR) public assertion that FORCES is a tobacco industry ally and front group was incomplete. I failed to mention that in a separate document, ANR appears to me to accuse FORCES of simply being a tool that is mobilized by the tobacco industry to fight smoke-free ordinances, and that despite its accusation that FORCES is a Big Tobacco front group, ANR admits that there is no evidence showing that FORCES is financially supported by the tobacco industry.

In the document, entitled "What to Expect from the Tobacco Industry," ANR states: "Tobacco companies seeking to have the appearance of local grassroots support will try to identify and mobilize smokers in opposition to smokefree air proposals. ... Keep your eyes and ears open for the following groups in your community. If you are concerned about other groups, contact ANR for assistance in uncovering any potential tobacco industry ties. ... FORCES International,, often sends action alerts to generate noise in opposition to smokefree laws. They typically cite tobacco industry-funded research or messages. Although there is no direct evidence showing that FORCES is supported financially by the tobacco industry, it frequently parrots industry arguments and material."

The Rest of the Story

The implication is that FORCES is simply a tobacco industry tool for opposing local smoke-free ordinances. If FORCES shows up in your community, you can be sure that Big Tobacco is in town. It appears to me that ANR is suggesting that the connection between FORCES and the tobacco industry is definitive, because only if you are concerned about other groups do you need to obtain assistance from ANR in "uncovering any potential tobacco industry ties."

For the longest time, I assumed that FORCES was funded by Big Tobacco because of ANR's assertion. I also believed ANR that FORCES was simply a tool of the tobacco industry. It was only when I took the time to myself examine the evidence that I realized ANR was misrepresenting the facts in what I became convinced was an attempt to mislead people into thinking that FORCES was nothing other than a front for Big Tobacco.

But ANR admits not just that the evidence on whether FORCES is funded by Big Tobacco is inconclusive, as I stated yesterday, but that there is no evidence that FORCES is funded by Big Tobacco.

I've heard of evidence-based public health, but this is the first I've heard of no-evidence-based public health.

Monday, November 21, 2005

IN MY VIEW: Show Us the Evidence - Time for ANR to Document FORCES' Tobacco Industry Funding or Remove it from its Website

Those who have been reading my posts over the past week will know that I have recently come to the conclusion that a number of anti-smoking groups are very interested in the science behind what they are doing only when that science supports their pre-determined agenda. Or perhaps it is more accurate to say that they tend to interpret the science in a way that supports their pre-determined agenda, rather than to let the science dictate the agenda in the first place.

While most of the examples I have provided relate to the justification for various tobacco control policies, I now share an example of an anti-smoking group ignoring the clear "scientific" evidence in order to support what I think is its pre-determined agenda to attack a group that it doesn't like.

In its section on front groups, Americans for Nonsmokers' Rights (ANR) lists FORCES and states that "the background information from this document [a document revealing that the National Smokers' Alliance was formed by, and funded by, Philip Morris and was therefore a Big Tobacco front group] is still relevant to other smokers' rights groups such as FORCES."

While the actual title on the page is "Front Groups & Allies," I think it's a fair inference that ANR is accusing FORCES of being a front group rather than merely being an ally for two reasons:
  • ANR puts FORCES in the same category as the National Smokers' Alliance (NSA), a true front group, and claims that the information related to the funding of the NSA is "still relevant" to FORCES; and
  • ANR provides a detailed discussion of the financial connections between FORCES and Big Tobacco, including the issue of whether FORCES is funded by the tobacco industry.
In order to help evaluate the evidence behind ANR's attack on FORCES, ANR provides a definition of "front group" that we can use. It links to the following definition: "A front group is an organization that purports to represent one agenda while in reality it serves some other party or interest whose sponsorship is hidden or rarely mentioned. ... For example, the Center for Consumer Freedom (CCF) claims that its mission is to defend the rights of consumers to choose to eat, drink and smoke as they please. In reality, CCF is a front group for the tobacco, restaurant and alcoholic beverage industries, which provide all or most of its funding."

Essentially, I believe that ANR is making a public accusation (even if by inference) that FORCES is a Big Tobacco front group that is funded, at least in part, by Big Tobacco.

The Rest of the Story

Let's examine the evidence that ANR provides to back up its accusation that FORCES is a Big Tobacco front group.

According to ANR: "For years FORCES has claimed to be a membership organization that did not receive tobacco funding. Internal tobacco industry documents are inconclusive on this point...".

It's pretty pathetic if this is the best that ANR can do. The organization itself admits that the evidence is "inconclusive." Well if the evidence is inconclusive, then it most certainly does not support a conclusion that FORCES is a Big Tobacco front group.

What I think is going on here is that ANR has come to a pre-determined conclusion that FORCES is a front group for the tobacco industry and ANR is essentially ignoring the fact that the evidence simply doesn't support its conclusion, or else it is interpreting the evidence in such a distorted way in order to make it appear that it supports its conclusion.

I don't think there is any evidence to support a conclusion that FORCES is a Big Tobacco front group. And there is a lot of evidence that it is not. I have had the opportunity to learn a lot about FORCES and its members over the past few months, and I've been educated. I had been greatly misled by ANR and I found out that the truth is entirely different from what ANR had led me to believe.

But even if the evidence were truly inconclusive (and not conclusive that FORCES is not a tobacco front group), I believe that the burden of proof is on ANR to prove it. Because you just don't make a public attack without being able to document your claims.

Even the definition ANR relies upon for front group makes it clear that a number of smokers' rights groups may not, in fact, be front groups because they are "self-initiated" rather than initiated by the tobacco companies:

"The shadowy way front groups operate makes it difficult to know whether a seemingly independent grassroots is actually representing some other entity. Thus, citizen smokers' rights groups and organizations of bartenders or restaurant workers working against smoking bans are sometimes characterized as front groups for the tobacco industry, but it is possible that some of these groups are self-initiated... ."

I think ANR should have paid a little more attention to the definition it is relying upon and realized that smokers' rights groups may be self-initiated, rather than initiated and run by the tobacco companies. In this case, the former is true, not the latter. Unless ANR can document that the latter is the case, their attack is simply not substantiated.

Now even if the issue is whether FORCES is a Big Tobacco "ally," I believe the evidence supports a conclusion that there is no alliance between the two groups. Because by definition, an alliance requires that the two groups form a connection between them. But there is simply no formal connection that I am aware of between FORCES and the tobacco companies.

Yes - perhaps the tobacco companies have pursued a possible alliance with FORCES in the past, and yes, perhaps, as ANR suggests, FORCES has pursued a possible alliance with the industry in the past. However, the important point is that those efforts did not result in an alliance.

The truth is that, as stated on its web site: "FORCES is a non-profit organization dedicated to the support and protection of consumers' rights. We advocate the restoration of the civil and human rights of ALL consumers. We have no link with the tobacco companies, and we are supported solely by member donations and volunteer work."

ANR is publicly claiming that FORCES is lying. In my view, that requires documentation. So it's time to show its constituents the evidence.

ANR should immediately provide to us its documentation for the claim that FORCES is funded by the tobacco industry and that there is a formal alliance between FORCES and Big Tobacco. If it cannot provide such documentation, then FORCES should be immediately removed from its web site. Anything less than that is a disservice to the public health community, as well as to the public who ANR is supposed to be serving.

Saturday, November 19, 2005

Premature Conclusions from Pueblo: More Information and More Research Needed Before Taking this to the Public

A press release issued on November 14 by the Pueblo City-County Health Department announced the results of a study which purported to show that the smoking ban in Pueblo, Colorado resulted in a 27% drop in hospital admissions for heart attacks. The study reported a 27% decline in heart attack admissions during the 18 months preceding the smoking ban (implemented in July 2003) compared to the 18 months after the smoking ban.

A press release issued the same day by the Campaign for Tobacco-Free Kids hailed the study as confirming that smoke-free laws reduce heart attacks, and concluded that this reduction in heart attacks occurred, at least in part, because of reductions in secondhand smoke exposure.

According to the Health Department press release: "The study validates previous scientific evidence that indoor smoke-free laws can dramatically reduce heart attacks and means that 108 fewer people had heart attacks in Pueblo in an 18-month period."

The headline of the Tobacco-Free Kids press release read: "New Study Confirms Smoke-Free Laws Reduce Heart Attacks, Shows Need to Make All Workplaces Smoke-Free."

I have already commented on what I think is the inappropriate and possibly inaccurate scientific conclusion of the Campaign for Tobacco-Free Kids that this study demonstrated a reduction in heart attacks due to reduced secondhand smoke exposure (rather than to reduced smoking by active smokers). Here, I comment on the overall conclusion that the study confirms that smoke-free laws reduce heart attacks.

The Rest of the Story

A critical piece of information is omitted from both the Pueblo Health Department press release and from the Campaign for Tobacco-Free Kids press release: that the expected number of heart attacks during the six-month period preceding the Pueblo smoking ban is substantially higher than the expected number of heart attacks during the six-month period after the Pueblo smoking ban.

The reason for this is that the six-month period preceding the Pueblo smoking ban includes the winter months, while the six-month period following the Pueblo ban includes the summer months, and heart attack admissions during the winter have been shown to be substantially higher than during the summer.

Since there were two winters and only one summer in the 18-month baseline period (before the smoking ban in Pueblo) and only one winter but two summers in the follow-up period (after the smoking ban), one would expect to see a decrease in the number of reported heart attacks, even in the absence of a smoking ban.

In fact, there are 53% more cases of acute myocardial infarction (heart attacks) during the winter compared to the summer (see: Spencer FA, Goldberg RJ, Becker RC. Seasonal distribution of acute myocardial infarction in the Second National Registry of Myocardial Infarction. Journal of the American College of Cardiology 1998; 31:1226-1233). In the Mountain region of the country (which includes Colorado), there are 50.3% more heart attacks during the winter than the summer.

A more important concern, however, is that an 18-month baseline period is probably inadequate to establish a stable baseline for comparison. It is not adequate, in my opinion, to:
  • establish the baseline seasonal variations in heart attack admissions;
  • establish the secular trend in heart attack admissions (changes in heart attacks over time); or
  • understand the variation in heart attacks from year to year, so that the differences in heart attacks from one period to the next can be meaningfully interpreted.
The problem is that we don't have an adequate idea of the number of, or range of the number of heart attack admissions that would have been expected in Pueblo in the absence of the smoking ban during the specific 18-month that included two summer seasons and only one winter season. This, in my mind, makes it extremely difficult to conclude that the observed changes in heart attacks in the study were attributable to the smoking ban, as opposed to simply chance variation or to some other factor.

Because of the inadequate baseline period of the study as well as the fact that there was a seasonal mismatch between the baseline and follow-up study periods, I do not think that the evidence presented supports a conclusion that 108 fewer people had heart attacks in Pueblo in an 18-month period due to the smoking ban (which I think the Pueblo Health Department implies) or that the study confirms smoke-free laws reduce heart attacks (as the Campaign for Tobacco-Free Kids states).

Is it likely that seasonal variation could explain a 27% drop in heart attacks in Pueblo during the 18-month period following the ban? Probably not. The seasonal variation is large, but probably not large enough to in and of itself explain a 27% reduction in heart attacks. Is it likely that the observed 27% decline reflects secular trends of decreasing heart attack incidence? Very possibly, since in at least one other city (Kent, Ohio) there was apparently a 34% drop in heart attack incidence during roughly the same time period. Is there a normal variation in heart attack incidence in Pueblo great enough so that a 27% decline would fall outside of the range of normal variation? That is impossible to know from the evidence that has been presented. I'd have to examine the actual data. And even having the actual data may not be sufficient, because as I stated above, an 18-month baseline period is probably not adequate to establish the underlying variation in heart attack rates over time.

The bottom line is that although the study presents data that is strongly suggestive of an effect of the smoking ban on reduced heart attacks, leaping to a definitive conclusion is not scientifically solid at this time. The new data may suggest an effect of the smoking ban, but they hardly validate or confirm that the smoking ban caused a reduction in heart attacks.

Thus, I think the conclusions that have been drawn from the evidence and disseminated to the public are premature. I think that the Pueblo Health Department and especially the Campaign for Tobacco-Free Kids have jumped the gun. The data were merely presented at a scientific conference - they have not yet been published or opened up to scrutiny. They have not even been released so that we can make our own judgment about the validity of the conclusions. In some circumstances, prematurely taking an unpublished study to the media is appropriate, but in this case, I tend to think not.

In my career so far I have almost never gone to the media with a scientific conclusion before my paper has been published. Why? Because I think there is a responsibility that comes with being in public service, and part of that responsibility is making data and methods publicly available so that independent judgment is possible. In this case, it is not. All we have are the biased conclusions of the Campaign for Tobacco-Free Kids, which, frankly, I do not trust.

I'll be very honest here. If this were a study of the economic impact of a smoke-free law in Pueblo, and the researchers compared restaurant sales data for an 18-month period prior to the ordinance to sales during the 18-month period following the ordinance, found a 27% decline in revenues and attributed that decline to the smoking ban, anti-smoking groups would blast the study as being seriously flawed.

In fact, anti-smoking groups would probably point out the 34% drop in "revenues" in Kent, Ohio during roughly the same period and suggest that the sales pattern in Pueblo could simply be reflecting secular trends.

They would, I am quite certain, attack the study for not having a long enough baseline period, for not having a sufficiently large comparison group, for not having accounted for secular trends in restaurant sales, for not having accounted for seasonal trends in restaurant sales, and for not being able to rule out the possibility that the 27% decline in sales was not simply within the bounds of normal variation in sales from year to year.

However, with the same study design, anti-smoking groups seem to be perfectly content to draw definitive causal conclusions when the observed effect is a positive one.

I am not concluding here that the observed reduction in heart attacks in Pueblo was not real or that it was not caused by the smoking ban, or even that there is not reason to believe that the reduction may have been attributable to the smoking ban. What I am saying is that I do not believe the evidence from this study, based on the information available to us, is sufficient to conclude that the smoking ban caused a significant decline in heart attacks and that the conclusion that the Campaign for Tobacco-Free Kids made and communicated to the public is scientifically shaky, in my opinion.

Most importantly, this is another example that is demonstrating to me that the science is not driving the anti-smoking agenda. Rather, the anti-smoking agenda appears to be driving the interpretation of the science.

The shame of this is that I think it is going to hurt the credibility of legitimate tobacco control research conclusions. If the public and policy makers realize that we are drawing scientifically shaky conclusions with respect to this research, what is to prevent them from dismissing the results of studies we publicize where the conclusions truly are scientifically solid?

The rest of the story suggests to me that anti-smoking groups are more concerned with the direction of the results of scientific studies than with the validity of the study conclusions, and that they are letting the agenda drive their interpretation of the science, rather than demanding that the science be used to drive the agenda. Anyone familiar with my work knows that I highly value the particular agenda that is being promoted here - but I would never promote it myself on the kind of weak science that is being used to do so. And I think that hurts, rather than helps, the pursuit of some important public health goals.

Friday, November 18, 2005

CHALLENGING DOGMA (Post #8): The Anti-Smoking Agenda Justifies Itself

One of the lessons that I have learned during the past 2 weeks (since I questioned the justification for policies in which employers refuse to hire smokers and for broad outdoor smoking bans) is that there are a considerable number of anti-smoking groups/advocates who are just not interested in discussing the justification for their tobacco control policies.

One of the responses I received to my posts questioning the justification for these two particular trends in anti-smoking policies was that there are more important things we need to do and discussion of these issues is a distraction to the important work that we should be doing. I also heard from one anti-smoking advocate who expressed a lack of interest in discussing the justification for these policies in the first place.

Apparently, there is a feeling that the agenda, being a well-intentioned one with a good end in mind, justifies itself.

It was interesting to me, because this wasn't the first response I received. The responses came in waves, and here's how I summarize them:

In the first wave, there was an attempt to dispute my suggestion that there is not adequate scientific evidence that outdoor smoking in open, non-enclosed places where people can freely move about is a substantial public health problem. I was referred to a study and told that I am not up to date on the facts.

While I had read that study, I re-read it, and still did not find evidence that outdoor smoking in most public places is a substantial public health problem.

When I pointed out that the evidence was unconvincing, that's when a slew of alternative possible justifications for outdoor smoking bans were suggested (the second wave) - everything from the need to control the litter on beaches to smoking being a nuisance to the desire to keep kids from seeing people smoke to smoking in public being a moral affront.

When I suggested that these justifications were not adequate, that's when the third wave of responses came in:
  • this discussion is a distraction that is taking us away from the important work we need to be doing; and
  • we are not interested in discussion that challenges the justification for what we are doing.
In other words, what I'm saying is that anti-smoking groups did not immediately express a lack of interest in discussing the issue. They were interested enough to point me to scientific data that they thought could convince me that secondhand smoke exposure outdoors is a substantial enough public health problem to justify broad outdoor smoking bans. But when I challenged whether that data actually demonstrated that the problem was a substantial one that was actually causing significant morbidity, they resorted to a second wave of arguments.

So there was some interest in the science behind the issue, but only an interest if the science supported the agenda. Once it became apparent that I wasn't going to buy the notion that the science supported the agenda, then the science no longer was critical. There were, after all, other reasons to support these policies.

After seeing that I wasn't convinced that these other reasons supported the agenda, that's when it became clear that a number of groups/advocates just aren't interested, when it really comes down to it, in the justification for what they are doing. They are doing it for a good cause, so it is by definition justified.

The Rest of the Story

I guess the thing I'd like to emphasize is that I view public health as a public service career. We are, first and foremost, public servants who are trying to advance the best interests of the public, focusing of course on the protection of the public's health. And to accomplish that end, we are promoting policy changes that are going to interfere with the way in which people live their lives. That's fine, but it means to me that we need to be able to adequately justify the need for intervention.

As public servants, I think we owe it to our constituents (the public) to be able to provide a solid justification for our interventions, especially those which intrude upon the freedoms and liberties of citizens.

And a solid justification, to me, implies that we need to be able not only to show that our proposed policies are going to benefit health, but that they are going to not harm the public, represent a just policy, and demonstrate respect for the autonomy of persons (specifically, that the benefits of the policy should outweigh any intrusion into individual autonomy).

In a recent article in Tobacco Control, Brion Fox of the University of Wisconsin Comprehensive Cancer Center beautifully articulated the ethical principles that tobacco control practitioners must consider in their work (see Fox BJ. Framing tobacco control efforts within an ethical context. Tobacco Control 2005; 14[Suppl II]:ii38-ii44).

The first principle, of course, is beneficence: "the duty to act for the benefit of others." Essentially, as Fox explains, this means "an effort to do good." This is clearly part of every tobacco control policy that is proposed. However, it is not the only ethical principle. The justification discussion does not end here. But it is at this point that I sense many anti-smoking groups feel that the discussion should end or that it simply does end.

As Fox points out, there are a number of other ethical principles that must also be considered.

One is the principle of non-maleficence: "the duty to do no harm." As Fox points out, "inattentiveness to negative consequences is ethically risky and could allow the community to be characterised as unconcerned. For example, the negative consequences of increased tobacco taxation on low income populations should be thoughtfully considered so as not to appear that the community is insensitive to the needs of this population."

I would argue that the principle of non-maleficence also needs to be considered in the issue of firing or not hiring smokers. Such a policy would have a severe negative impact on the ability of smokers to find employment and therefore to make a living and support themselves and their families. To simply toss this concern aside is, as Fox suggests, "ethically risky."

Just yesterday, I suggested that the principle of non-maleficence was violated by the Georgia workplace smoking law, which actually harms restaurant workers who are forced to work under the extremely dangerous conditions of smoke-filled smoking rooms.

Another principle that Fox outlines is that of justice: "the duty to act with fairness." For example, Fox points out that "as the tobacco control community advocates for increased taxes, the possible regressivity of these taxes should be clearly considered and efforts made to limit any impact that could increase disparities."

I would argue that this principle applies importantly to the consideration of discriminatory workplace policies. Is it fair to smokers to make employment decisions based on their membership in a particular group or category, rather than on the basis of their individual qualifications for a particular job?

Perhaps the most overlooked principle is that of respect for autonomy: "the right to be free from controlling influences." Fox emphasizes that the autonomy of smokers must be considered: "the tobacco control community should show that it respects the autonomy of all individuals, including smokers, by demonstrating how its programmes are consistent with this principle."

Here is where Fox has elegantly made the primary argument that I am trying to make. It isn't enough for a proposed anti-smoking policy to be benificent - that is, to be intended to promote health. It also has to respect individual autonomy. And to respect autonomy, tobacco control practitioners must demonstrate "how its programmes are consistent with this principle."

In other words, the burden of proof is on us. Our policies are not self-justifying. We must specifically show how they take into account the ethical principle of autonomy, we must demonstrate that the benefits of the policy outweigh any intrusion into individual autonomy. That is precisely what I mean when I talk of the need to adequately justify our policies.

It is not enough to say that outdoor smoking should be banned because it is a nuisance or because it causes a huge litter problem or because it leads kids to smoke, or even because it is a health hazard. We must demonstrate that the degree of the problem is substantial enough to justify the degree of intrusion into individual autonomy that the proposed policy represents.

With the case of outdoor smoking bans, I find the intrusion to be substantial, so I feel that the degree of the problem must also be substantial. And this is why the absence of scientific evidence that the problem is a major one from a public health perspective is so important to me.

It's not that I don't think banning smoking everywhere in public has some benefit or is intended to protect health. It's that banning smoking everywhere in public intrudes upon personal autonomy and it's not clear to me that the benefit in terms of protecting health outweighs the degree of the intrusion. That's the issue that I've been trying to bring to the forefront, apparently unsuccessfully.

Perhaps my frustration with the response to my recent posts is that many anti-smoking advocates and groups tend to speak only in the language of beneficence. If it is intended to improve health, then it is automatically justified.

But as Fox insighfully points out, this is just one of a number of ethical principles that must be considered. A proposed policy must also not do harm, must be fair, and must respect the autonomy of persons, and that includes smokers.

What I am trying to do is to make sure that, in our role as public servants, we are being true to our responsibility to consider all of these ethical principles: non-maleficence, justice, and respect for autonomy (Fox also includes transparency and truthfulness, which I address repeatedly in many of my posts about the tobacco control movement), and not just beneficence.

The rest of the story is that the anti-smoking agenda does not justify itself. It is our duty, our obligation, our public responsibility to demonstrate that our proposed policies are justified. And to do this, we must not simply show that a policy is beneficent; we must also show that it will not cause undue harm, that it is fair, and that it respects autonomy (that the health benefits outweight the degree of intrusion into individual autonomy). We must also be forthright (transparent) and honest in all of our efforts to promote these policies.

To me, this is what would make the difference between being simply an anti-smoking movement and truly being a public health movement that is dedicated to the reduction of tobacco-related suffering.

Physicians for a Smoke-Free Canada Proposes Government Buyout of Tobacco Industry with Transfer of Industry to Non-Profit Corporation: An Absurd Idea

Three weeks ago, I commented on the Physicians for a Smoke-Free Canada (PSC) proposal for a government buyout of Canadian tobacco manufacturers, with the government to run the country's tobacco business or see to its administration by a non-profit entity. At that time, I was analyzing the PSC summary of the proposal, but had not read the entire book that describes and defends the proposal.

I have now read the book and will comment on it (see: Callard C, Thompson D, Collishaw N. Curing the Addiction to Profits: A Supply-Side Approach to Phasing Out Tobacco. Ottawa: Canadian Centre for Policy Alternatives and physicians for a Smoke-Free Canada, 2005).

The basic premise of the book is that the chief problem with tobacco products in our society is that the tobacco industry which produces, sells, and markets them is a for-profit industry that has no inherent interest in doing anything but making a profit, and therefore it opposes and undermines any public health efforts (e.g., laws, policies, and programs) to attempt to reduce tobacco consumption.

The proposed solution is to have the government buy out the tobacco industry and place it in the hands of a non-profit corporation (such as a public interest enterprise, non-profit business, or publicly-owned enterprise), which would produce and sell tobacco products, but without huge marketing expenditures and without opposing public health efforts to reduce tobacco consumption.

The premise, succinctly put, is that "we can be more effective by transforming big tobacco into a public health ally." ... "There is no reason that tobacco 'has to' be sold by business corporations. There are many other institutional forms to whom the business of providing tobacco could be entrusted." ... We need to "move on to an era of a cooperative tobacco industry that helps us to reduce tobacco consumption." ... The goal is "to remove the corporate behavior that impedes reducing the problems that tobacco causes. ... We can choose a tobacco industry that works to support and promote health protection measures instead of one which undermines them."

The proposal will "point the way forward for a tobacco manufacturer that could help promote public health, instead of promoting tobacco consumption." ... It would "help create a corporate culture of commitment to public health improvement. All employees would become part of an exciting new public health enterprise. Instead of selling more and more cigarettes, the corporation would actually give customers what the vast majority of them want - help with quitting smoking."

"Our proposal," the book argues, "provides users with the substance they want, while offering assistance in quitting to the vast majority who do want to quit."

The legislated mission of the non-profit corporation would be "to take all steps within its power to reduce tobacco consumption...".

The estimated cost of buying out the tobacco industry in Canada is $15 billion. How would this money be re-captured? According to the book: "A portion of the purchase cost debt could be repaid by future revenues from the sale of tobacco products. ... After the debt is paid off, the profits from the industry, once they paid off the debt, could contribute significantly to government coffers."

The Rest of the Story

After reading the book, I think this has got to be one of the most absurd public health ideas I have ever heard.

Right off the bat, putting the government in a $15 billion hole (that's the estimated cost to buy out the tobacco industry in Canada), with the only way out of that hole being to sell cigarettes that are going to kill thousands of Canadians, seems crazy to me. What it would do is to make the government dependent on killing people, essentially, in order to remain solvent. That is insane to me.

Not only that, but once the debt is paid off, the government will be filling its coffers with tobacco revenues, as admitted in the book, and this money will certainly be used to fund government programs and services. Thus, the government will become addicted to tobacco money; it will be heavily dependent on sustained tobacco consumption for its own sustenance.

These are certainly not the conditions under which tobacco consumption could reasonably be expected to drop drastically, as the book posits it will. It will destroy any incentive whatsoever for the government (at both the national and provincial levels - since tobacco revenues would fill coffers of both) to enact effective policies to reduce tobacco use. Doing so would result in economic harm.

We have already witnessed, here in the U.S., what the Master Settlement Agreement has done in terms of protecting the tobacco industry's interests by creating a partnership with the states, who are now dependent upon tobacco revenues to fund critical programs and services.

It is difficult enough to get policy makers to take appropriate actions that are necessary to effectively address the public health problem of tobacco use. The last thing in the world I would recommend is making the government irretrievably dependent upon tobacco revenues for its own solvency.

Perhaps even more absurd than the plan itself is the reasoning behind it. The premise is essentially that tobacco is a public health problem because the cigarette companies are making profits off of it and the profit incentive causes the tobacco industry to oppose and undermine public health programs to reduce tobacco use.

That's not how I define tobacco as a public health problem. To me, tobacco is a public health problem because it kills large numbers of people. I don't care who is making profit off of it, if anyone. It is the fact that tobacco is killing people that makes this a problem, not who is selling it and who is profiting from it and what incentive particular groups have to take particular actions. Taking away the profit motive doesn't take away the fundamental problem: tobacco products are deadly. Period.

A fundamental flaw in the argument presented in "Curing the Addiction to Profits" is that it is even possible for a tobacco industry to be a "public health ally." How can a corporation that is producing a product that is killing thousands of citizens be a public health ally? It's just a ludicrous concept.

Taking away the profit motive does not suddenly make a tobacco manufacturer a public health ally. If you are producing a product that kills thousands of people, you are no friend to public health in my book. I don't care how much you might work to try to dissuade people from smoking. The fact is - you're producing a product that is killing people - and that precludes you, in my view, from being a friend to the public's health.

And you can't with a straight face legislate the goal of the non-profit entity as being "to take all steps within its power to reduce tobacco consumption" because one step that would certainly be within the power of the corporation would be to stop producing the product and therefore to stop killing people. By definition, the legislative mandate of the corporation would be to produce the product and continue to kill people.

Another fundamental flaw in the argument presented is the fantasy-like assertion that the elimination of the profit motive and the concomitant elimination of massive advertising and promotion expenditures to market cigarettes is going to result in the virtual elimination of demand for cigarettes.

I won't quibble with the claim that cigarette consumption would be reduced if cigarette marketing were eliminated, but I certainly don't find any reasonable evidence that it would end the demand for cigarettes.

What the proponents of this idea don't seem to realize is that the greatest marketing for cigarette use is the product itself. It is seeing other people smoking that is the greatest and most effective advertisement for cigarettes. You can take cigarette ads off all the billboards and out of all the magazines and you can stop paying retailers to stock certain brands and offer price discounts, but as long as people are smoking the product, it is going to market itself.

Producing a product that people can use and making the product easily available to them are perhaps the top two marketing tools available, and those marketing tools would most certainly be used by the non-profit corporation to "promote" its products, even in the absence of traditional advertising.

The book suggests that cigarette consumption in Canada will drop to zero by 2030 based on an linear extrapolation of smoking prevalence trends over the past five years. That is scientifically fallacious in my opinion. To begin with, it's cherry-picking. One could choose any period in which consumption is falling and conclude that the trend will continue. But if you look at the overall trends in smoking in Canada (or in the U.S), you will see that the rate of decline in smoking has greatly slowed down. One would not expect the rates to continue to decline at this pace, especially since the remaining smokers will represent a much more heavily addicted and more resilient group over time.

In fact, I don't see any convincing argument in the book for why tobacco consumption will decline rapidly in Canada after "de-profitization" of the tobacco industry.

In many ways, the book is suggesting that the solution to the problem is to structure the tobacco industry in a way similar to that in a country like China, where the tobacco industry is a state-run enterprise: a state monopoly. But arguably, the problem of tobacco use in China is the world's greatest public health problem: it is killing nearly 1 million people each year. Clearly, it's not the competitive market and profit motive that's killing people - it's the cigarettes!

On top of all of this, the book proposes to deny Canadian citizens of their legal rights to hold the tobacco industry accountable for damages caused by their products: "there would be no more need for tobacco litigation. ... The member/shareholders, directors and managers in the new organizations would need to be legislatively protected from lawsuits for the past wrongs of the for-profit tobacco industry."

Canadian citizens would be stripped of their legal rights and the non-profit entity would be essentially non-accountable to citizens through the legal system. I think this represents an intrusion into the civil justice system and an interference with individual rights that would be highly questionable even if the proposal were tenable, but it is unthinkable in a situation were the proposal is this absurd.

In all fairness to Physicians for a Smoke-Free Canada, they are not the first to propose such an absurd idea. The first I heard of this idea was from none other than former FDA Commissioner Dr. David Kessler, who in his book "A Question of Intent: A Great American Battle with a Deadly Industry," proposes a very similar "solution" to the tobacco problem.

I think it is a shame that the book, after pages and pages of data about how terrible it is that people are smoking such a deadly product, concludes by suggesting that the solution is simply to have the government buy out the industry and transfer it to a non-profit entity, who would now be the ones to produce, sell, and reap in revenues from this deadly product.

The rest of the story suggests to me that the problem of tobacco is not going to be solved until first, public health practitioners are able to define the problem of tobacco. Tobacco is not a public health problem because an industry makes profits off of it or because the incentives to decrease tobacco use are non-existent in the industry or because the industry opposes and undermines public health measures. Tobacco is a public health problem because it kills a lot of people. Until we can define the problem properly, we're not going to solve anything.