Wednesday, October 18, 2006

Former FDA Commissioner Pleads Guilty to Lying About Holding Stocks in Companies He Regulated

According to an Associated Press article, former FDA Commissioner Lester Crawford pleaded guilty yesterday to charges of conflict of interest - holding stocks in companies that he [FDA] regulated - and lying about that conflict of interest.

"Former FDA Commissioner Lester Crawford pleaded guilty Tuesday to conflict of interest and false reporting of information about stocks he owned in food, beverage and medical device companies he was in charge of regulating. Crawford admitted to falsely reporting that he had sold or did not own stock when he continued holding shares in the firms governed by rules of the Food and Drug Administration. Beginning in 2002, Crawford filed seven incorrect financial reports with a government ethics office and Congress, leading to the charges. ... The two charges -- conflict of interest and false reporting -- are misdemeanors and each carries a maximum penalty of one year in prison and a $100,000 fine. ... 'Nothing that I have done, I hope, can be construed to affect the integrity of the FDA,' said Crawford, adding that he had worked at the agency four times over 30 years."

The Rest of the Story


Right! In no way does this affect the integrity of the FDA. In no way can the fact that the FDA Commissioner illegally earned tens of thousands of dollars in dividends or by exercising stock options in companies that he regulated be construed to affect the integrity of the FDA. In no way is the integrity of FDA affected when its chief commits a federal misdemeanor - a crime that could be perceived as influencing the regulatory decisions made by the Agency. And in no way should we think that the integrity of FDA is affected when its chief lied about all of this.

Apparently, Crawford just doesn't get it. What he did was a crime specifically because it undermines the integrity of the FDA. It's like the chief executives of Enron pleading with the public not to interpret any of their illegal actions as a slam on the Enron corporation.

Crawford was said to be "choked up" and apologetic when he spoke to reporters outside the courthouse, but if he was really apologetic and really deserved forgiveness, he would have admitted that his actions did affect the FDA's integrity. His failure to admit that basic fact demonstrates a lack of understanding of the severity of his actions and eliminates any spirit of forgiveness that I might otherwise have felt.

The importance of this story to tobacco control is that this is the precise federal agency that the Campaign for Tobacco-Free Kids (TFK) wants to place in control of all aspects of tobacco regulation. And TFK is under the impression that the FDA will take actions that will substantially change the way that tobacco is manufactured in this country, even if such drastic changes would severely harm the profits of the tobacco companies.

For this kind of nonsense, TFK is willing to essentially give up future tobacco litigation, the ability of states to regulate tobacco, and the incentive for states to take on the tobacco issue in the first place?

And things don't seem to be much better with the current FDA Commissioner. Not in terms of illegal stocks or dishonesty, but in terms of the presence of conflict of interest that affects the integrity of the Agency.

Remember that back in October 2005, I wrote:

"To make matters much worse, The Cancer Letter reports that politics and dismissal of ethics has infested the highest level of the FDA and the HHS (Department of Health and Human Services). According to the article, Acting FDA Commissioner Andrew von Eschenbach (a family friend of President Bush) was cleared to head NCI and FDA even though heading both organizations represents a clear and unmanageable conflict of interest. While NCI "has vested interests in many compounds and works in partnership with pharmaceutical companies, FDA has the power to stop trials to protect patients from unwarranted risk. Most importantly, the agency approves drugs."

In addition, an even larger conflict of interest arises because Von Eschenbach is not only head of the FDA but also vice chairman of the board of C-Change, "a coalition of cancer groups heavily funded by pharmaceutical companies and headed by former President George Bush and his wife Barbara Bush. Peter Dolan, CEO of Bristol-Myers Squibb Co., and Gary Reedy, a vice president at Johnson & Johnson , also hold board seats."

How can Von Eschenbach possibly regulate the pharmaceutical industry and properly protect the interests of human research subjects and patients across the nation if he heads a group that is heavily funded by the pharmaceutical industry and runs that group shoulder-to-shoulder with the heads of pharmaceutical companies?

The fact that Von Eschenbach was cleared for such a role despite these inherent conflicts of interest suggests, according to the article, that politics, rather than the public's health, is now dictating policy in HHS, including at the FDA.

Perhaps the most telling quote comes from Michael Clark, a former federal prosecutor who is now a private attorney and editor of the LJN Bioethics Legal Review: "If this were a horse race, Dr. Eschenbach would be a 'trifecta' pick for conflicts of interest by adding the FDA to his NCI and C-Change affinities."

Merrill Goozmer, the director of the Integrity of Science Project at CSPI (Center for Science in the Public Interest) stated: "So here you have companies who are bringing products before FDA, and he is sitting on the board of a non-profit organization with them; what more do you have to say? It's a conflict of interest for the same reason that we don't allow the head of the Securities and Exchange Commission to own stock in the companies he is auditing."

Alan Milstein, a New Jersey health care attorney, expressed his concern that the very health of the American people is being placed in jeopardy because of the conflicts of interest that the government has waived: "Human subjects will be left without the protection of the government. When you are talking about cancer patients in trials, who are desperate for a cure, they are a vulnerable population. These are a class of subjects who need protection...This is the head of the FDA! If you need to set up a mechanism by which this guy avoids conflicts of interest, then he shouldn't be there."

The rest of the story is that the integrity of the FDA is at an all-time low. Putting regulatory authority over tobacco products into the hands of this agency at this time is about the last thing in the world that I think public health practitioners should want to do. But the insult to the injury is that the proposed FDA legislation isn't even strong public health legislation. It contains unprecedented special protections - truck-sized loopholes - for Big Tobacco. I guess being regulated by an Agency that allows financial and political interests to dominate over public health concerns is just another special protection that Big Tobacco will be able to enjoy if TFK is successful in fulfilling Philip Morris' wish.

Tuesday, October 17, 2006

After Lots of Fanfare, McCallum Deposition Turns Up Nothing

It received lots of fanfare, but the deposition of former Associate Attorney General Robert McCallum turns up no evidence that he did anything wrong in his handling of the DOJ tobacco litigation or in his response to a FOIA request from Citizens for Responsibility and Ethics in Washington (CREW).

After a lot of fanfare, CREW won a court decision that forced the release of McCallum's videotaped deposition. While the videotape is not immediately available online, the text of the deposition is.

And let me tell you, you won't want to stop what you're doing to read that text. Despite all of the public brouhaha made by Americans for Nonsmokers' Rights (ANR) and the Campaign for Tobacco-Free Kids (TFK) about McCallum's supposed ethical violations in his handling of the tobacco case, there is absolutely nothing in the deposition that suggests any wrongdoing occurred.

If ANR and TFK are looking for evidence to support their public attacks on McCallum - evidence that they should have had prior to issuing their attacks - they are certainly not going to find it here.

If anything, the deposition casts McCallum as reluctant to intervene in the actions of the trial team except in the desperate circumstances when they seemed to be ignoring the dictates of the appellate court and when their expert witnesses appeared ready to base their testimony on remedies that were not allowable under the Appeals Court decision.

The Rest of the Story

It seems to me that with the Foley scandal, with pages being sexually harassed, there are a lot better uses of taxpayer money to conduct ethical investigations than having to go through the hours and hours of seemingly wasted time questioning McCallum about actions that appear to be entirely appropriate, just because a few anti-smoking organizations and politicians seem to want to make a political issue of this.

In light of the lack of anything of interest in the deposition, despite the great buildup preceding its release, and in the spirit of David Letterman, I therefore offer my top ten list of things to do instead of reading Robert McCallum's videotaped deposition. These are the most boring things I can think of, yet they offer far more excitement that plowing through this document in search of damning evidence, expected based on TFK's and ANR's claims, that simply is not present.

Top 10 List of Things to Do Instead of Reading Robert McCallum's Videotaped Deposition

10. Attend a curling match
9. Watch television re-runs of What's Happening
8. Watch any Temple football game this season
7. Listen to Wagner's Ring Cycle
6. Watch the first quarter of a professional basketball game
5. Listen to three Philip Glass albums in a row
4. Watch four hours of golf without any beer
3. Be a spectator at a chess tournament
2. Sit through the Ohio State graduation ceremony
1. Stand on line at the Department of Motor Vehicles to renew your license a year early

New Zealand Health Group Calls Smoking By or Around Pregnant Women Child Abuse

A New Zealand health group - the Maori Heart Foundation - is arguing that smoking by or around a pregnant woman is child abuse.

The Foundation issued a press release yesterday which stated:

"Smoking during pregnancy, or smoking around a pregnant women is yet another form of child abuse, the Maori Heart Foundation Te Hotu Manawa Maori (THMM) said today. ... As an organisation, we'’ve looked at the definitions of child abuse, and there'’s no doubt in our mind that smoking during pregnancy, and smoking around your children constitutes physical abuse. When we look at legal and policy guidelines, it'’s very clear that smoking during pregnancy is abusive to children. Child Abuse means the harming (whether physically, emotionally or sexually) ill-treatment, abuse, neglect or deprivation of any child or young person. Physical Abuse is any act or acts that result in inflicted injury to a child or young person."

The Rest of the Story


There are a number of severe problems with this argument. First, it confuses the concepts of injury (harm) and risk. There is little doubt that smoking during pregnancy increases the risk of a number of adverse health conditions. But it doesn't necessarily cause harm. As the Foundation itself admits, physical abuse is an act that results in inflicted injury. Since smoking during pregnancy or around a pregnant woman does not usually inflict injury, it is not physical abuse.

It is important to recognize that by the Foundation's definition of child abuse, any woman who takes a drink of alcohol during pregnancy is a child abuser. There is strong evidence that alcohol use during pregnancy increases the risk of adverse health outcomes. Any woman who drives in a car during pregnancy is also a child abuser. Riding in a car increases the risk of injury and death. So does changing cat litter while pregnant, another form of child abuse according to the Maori Heart Foundation's definition. And I don't even want to talk about pregnant women who eat raw fish. That increases the risk of intestinal infection, which could cause adverse consequences that harm the fetus, and represents child abuse, according to the Foundation's definition.

You can see how dangerous this type of argument is. If we adopted such a definition here, as suggested by Action on Smoking and Health, Smokefree Pennsylvania, and a number of other anti-smoking groups and advocates (they have argued that smoking around a child is a form of child abuse), then any parent who allows their child to ride on a roller coaster is a child abuser. Letting your child play hockey is a serious form of child abuse. Parents of children who are allowed to play football are also child abusers, according to this argument.

A second problem with the argument is that it would treat people who smoke around children, or pregnant women who smoke, in the same way as people who beat their children. If we are unable to see a world of difference between these, then we have some serious problems that could truly put our children at risk. Ultimately, society addresses child abuse by removing children from the custody of their parents. Resorting to such an approach to deal with smoking would be a tragedy and would cause every bit as much harm to children as is being caused by tobacco smoke.

Third, the argument that smoking during pregnancy is child abuse rests on making and enforcing a societal decision, that must be accepted by all, that life begins at conception. This is the ultimate infringement upon personal freedoms and rights. It essentially destroys the autonomy of women, and ends the concept of abortion rights. It is a particularly dangerous and alarming sequela of the kind of argument that the Maori Heart Foundation is making.

A fourth flaw in the Foundation's argument is that child abuse and physical abuse are terms that generally imply an intent to cause harm. The action that causes the harm is the primary intention of the perpetrator.

For example, when someone beats a child, the primary intent of the action was to beat the child. It is not the case that hitting the child was a secondary, unfortunate side effect of some other primary action.

But in the case of smoking around a child or a fetus, it is not the primary intent of the alleged perpetrator of the "child abuse" to injure the child or fetus. The injury, if it does occur, happens as an unfortunate, unintended secondary consequence of the primary action, which was simply to smoke.

This is also why driving with kids in a car at 60 miles an hour on a crowded Los Angeles freeway is not child abuse, nor is changing a cat litter and getting toxoplasmosis, which can result in severe neonatal injury or death. The primary intention of the act of driving was not to injure a child, it was to get somewhere. Similarly, the primary intention of changing the cat litter was not to harm the neonate; it was to change the cat litter.

This is not the case with beating or sexually abusing a child, where the beating or the forced sex is the primary intent of the action, not a secondary, unintended consequence.

Apparently, those of us in tobacco control are unable to make these important distinctions. But we had better learn, and pretty quickly.

I hope that other anti-smoking groups will condemn this approach to the problem of smoking during pregnancy and exposure of children to secondhand smoke. But as I said earlier today, I'm not holding my breath.

Contra Costa Times Article Questions Whether Anti-Smoking Measures Are Going Too Far

An article in yesterday's Contra Costa Times questions whether anti-smoking measures are going too far, especially by moving from smoke-free workplaces to smoker-free workplaces.

In the article, I am quoted, pointing out a number of arguments why I oppose smoker-free workplace policies that are being supported by several U.S. anti-smoking groups, and publicly opposed by none.

"This once black-and-white issue has grown gray for Boston University professor Michael Siegel, a tobacco control advocate. When Siegel learned that the Ohio-based Scotts Miracle-Gro Co. had unveiled a policy requiring employees to quit smoking or be fired, as well as prohibiting the hiring of smokers, he had to object. 'It's very troublesome to me because this is crossing the line from being an anti-smoking movement to an anti-smoker movement,' he said. 'It's one thing to clear out the smoke in a workplace, (rather) than the smoker from the workplace.' It also could lead businesses to not hire employees based on other health care concerns that could boost costs, such as obesity. Then, there's the concern about an employer asserting control over what workers do on their off-hours. 'I really think it's an undue intrusion into the privacy of employees,' Siegel said.

A Miracle-Gro representative describes the policy, which took effect this month, as a move to create a culture of wellness. She acknowledges that rising health care costs were a factor. Manager Su Lok says the company recently opened a multimillion-dollar wellness center, with a medical and fitness center. 'Our chairman's goal is to have associates who have a more balanced lifestyle. A component of that is becoming a tobacco-free culture workforce,' she said. The company reimbursed employees who attended smoking cessation courses before the announcement made nearly a year ago, Lok says."


The Rest of the Story


This is an important article, and I hope that many tobacco control groups and advocates see it, because it emphasizes the line between promotion of smoke-free workplaces and smoker-free workplaces. This is a line between what I view as public health and what I see as unjustified discrimination, lifestyle policing, and undue intrusion into privacy.

Scotts Miracle-Gro apparently defended its discrimination against smokers in hiring by arguing that it is trying to achieve "a more balanced lifestyle" among its employees. Thus, Scotts is readily admitting that this is indeed about becoming the lifestyle police for its workforce. What business does the company have policing the lifestyles of its employees, other than those aspects of lifestyle that directly affect job performance?

To promote healthy lifestyles through education, health services, and incentives is an appropriate public health intervention. Corporate wellness programs are a cornerstone of employee health promotion. But creating a workforce with a particular lifestyle that has no direct bearing on job performance by refusing to hire, categorically, members of a particular group, is not public health. It is employment discrimination, plain and simple.

I therefore agree with the California coordinator of the Smoker's Club, who argued that "smokers are being cast aside and discriminated against."

He is exactly right. Policies like that of Scotts Miracle-Gro, which are growing in number, do cast aside smokers and discriminate against them.

I'm still waiting for a U.S. anti-smoking group, any of them, to publicly condemn such discrimination. But I'm not holding my breath.

Monday, October 16, 2006

Smoking in Movies Called Greatest Media Threat to Children's Health

According to a press release issued by the American Academy of Pediatrics, two anti-smoking researchers have called smoking in movies the greatest media threat to children's health.

The press release opens: "While headlines have focused on violent video games and Web predators, the single greatest media threat to U.S. kids comes from tobacco-laced movies and videos according to James Sargent, MD, FAAP, and Stanton Glantz, PhD. As discussed today at the American Academy of Pediatrics (AAP) National Conference and Exhibition (NCE), three major population studies between 1999-2004 display a striking dose-response by adolescents to on-screen smoking in movies and videos: the more smoking children see on screen, the more likely they are to become smokers."

The solution to this problem, according to the researchers, is to require films that depict smoking to carry an R-rating. Dr. Glantz was quoted in an ABC News story as stating: "That one simple change in the rules, we think we would prevent about 200,000 kids a year from starting to smoke."

The Rest of the Story

What is not made clear in these news reports is that the claim that requiring a R-rating for movies that depict smoking would result in 200,000 fewer kids starting to smoke each year rests on the assumption that such an intervention would eliminate exposure to smoking in movies for one-half of all kids who are currently exposed to smoking in movies.

But there is no evidence (0.0 studies) that requiring an R-rating for movies that depict smoking would eliminate exposure to smoking in movies.

In fact, research published by one of the very researchers mentioned above documented that only 16% of kids are restricted from watching R-rated movies. So requiring an R-rating for movies depicting smoking would eliminate exposure to smoking in movies for only 16%, not 50% of kids.

And this assumes that parents do not change their behavior if smoking in movies results in an automatic R-rating. Another possibility is that such a move would undermine the current rating system, leading parents not to worry so much about whether their kids view such movies, because they may figure that it might only be smoking to which their kids are being exposed. In other words, the R-rating could become much less meaningful to parents as a way of knowing the movies to which their kids should be restricted if smoking automatically triggers an R-rating.

It is possible, in fact, that such an intervention could actually increase kids' exposure to violence and sex in movies, as parents may be less likely to restrict their childrens' access to R-rated movies.

The important point, though, is that even if there is no change in parental behavior, a whopping 84% of kids are allowed to see R-rated movies anyway. Thus, requiring an R-rating for movies that depict smoking would be expected to have only a marginal impact on eliminating youths' exposure to these depictions.

In fact, the study which found that 84% of kids are allowed to see R-rated movies argued that the appropriate intervention to reduce youth smoking is to try to encourage parents not to allow their kids to see R-rated movies. The article concluded: "Limiting the exposure of adolescents to R-rated movies may prevent early use of alcohol and tobacco."

It is important to note that based on this research, changing the rating of movies that depict smoking would have little impact on youth smoking, in contrast to the claim that such a move would prevent 200,000 kids a year from starting to smoke.

The bottom line is that the claim that requiring an R-rating for movies that depict smoking would prevent 200,000 kids a year from starting to smoke is unsupported by the evidence. It is pure speculation, and not even well-supported speculation at that.

A second assumption underlying this claim, which you won't read about in the news, is that exposure to smoking in movies does not correlate with exposure to other sources of media depictions of smoking, or to cigarette advertising, that may influence smoking initiation. It may be that seeing smoking in movies is simply a measure of a broader construct: overall exposure to smoking depictions from a wide array of media sources.

After all, movies are not the only source of media depictions of smoking. There are smoking depictions in music videos, on television, in magazines, and in cigarette advertising. To the extent that exposure to these depictions correlates with exposure to smoking in movies, the conclusion that it is purely exposure to smoking in movies that is causing nearly half of all kids to start smoking is inaccurate.

A third assumption underlying the claim, which you also won't read about in the news, is that the relationship between seeing smoking in movies and smoking initiation is not at all attributable to factors that correlate with parental styles regarding the restrictiveness of regulation of their childrens' activities. Is is not true that parents who never let their kids see an R-rated movie are probably different in many respects from parents who do let their kids see R-rated movies, and that these differences, rather than the movies itself, could explain some of the observed differences in smoking initiation rates?

These issues are discussed in some detail in an earlier post.

Whether or not smoking in movies is a substantial public health problem in its own right, it seems quite a stretch to claim that giving movies that depict smoking an R-rating will prevent 200,000 kids a year from starting to smoke. It is a stretch that goes beyond the realm of science.

Even if one were to accept that smoking in movies, in and of itself, is a major public health problem, it hardly seems like it would be at the top of the list in terms of the greatest media threats to childrens' health. I can tell you, working in the inner-city of Boston, that the depiction of violence, especially gun violence, on television and in movies is probably at the top of my list. We have already reached our 55th homicide in the city this year, and you would be hard-pressed to convince anyone living in Roxbury or Dorchester that people lighting up in movies is a far more grave threat to our children's health and welfare than the cultivation of a culture of violence.

I don't quite understand why we need to claim that our particular pet issue is the most important one in the world. Why, in the midst of a terrible problem of youths being murdered and families being scared about walking around on the streets, fearing for their lives, do we need to undermine this immediate life-threatening issue by blasting the public with the contention that smoking is the worst possible thing that a movie could show?

Frankly, it seems like a bit of an insult to parents of children who fear for their kids' safety just walking around in their neighborhoods at night.

It seems that every public communication by anti-smoking groups needs to be greatly exaggerated and blown out of all proportion. Tobacco control is just a part of public health. We shouldn't lose our broader perspective by working constantly with blinders on that shield us from seeing anything but the issue on which we are currently working.

Friday, October 13, 2006

Anti-Smoking Group Claims that 30 Seconds of Secondhand Smoke is As Bad As a Lifetime of Active Smoking in Terms of Coronary Artery Function

According to an article in the St. Paul Pioneer Press, a Minnesota anti-smoking group has publicly claimed that 30 seconds of secondhand smoke is as bad as a lifetime of active smoking in terms of coronary artery function. The group - Association for Nonsmokers (Minnesota) - issued a press release which declared that a mere 30 seconds of secondhand smoke exposure results in coronary artery damage that is indistinguishable from the damage suffered by active smokers (many of whom have smoked for decades).

According to the article, the Association for Nonsmokers press release claimed that: "Just 30 seconds of exposure can make coronary artery function of nonsmokers indistinguishable from smokers."

The Rest of the Story obtained a copy of the press release, dated August 30, which indeed stated:

"Research studies have shown that even just thirty seconds of exposure to secondhand smoke can make coronary artery function of non-smokers indistinguishable from smokers."

The Rest of the Story

The amount of time it takes to suffer severe damage from secondhand smoke keeps decreasing rapidly. First it was 30 minutes. Then 20 minutes. Then 5 minutes. Now it's down to 30 seconds. I can see why anti-smoking advocates in Omaha want nonsmokers to call 911 when they so much as see an ashtray.

Let's give the Association for Nonsmokers the benefit of the doubt and assume that this was simply a careless mistake, and that what they meant to say was that 30 minutes of exposure to secondhand smoke is indistinguishable from chronic active smoking in terms of coronary artery function.

If the Association for Nonsmokers' health claim is true, then there is no reason for smokers to quit smoking. Because if they are ever exposed to secondhand smoke for just 30 minutes, then their coronary arteries apparently have suffered damage equivalent to that from active smoking and the function of their coronary arteries is indistinguishable from that of active smokers. So why bother to quit smoking?

I guess we can add the Association of Nonsmokers to the list of more than 80 anti-smoking groups which are making fallacious health claims in order to promote smoking bans (an ultimate goal which I support, although I condemn the use of false information to promote this goal).

Obviously, this claim (even if corrected to 30 minutes rather than 30 seconds) is fallacious. The coronary artery function of chronic active smokers is clearly very different from that of nonsmokers who are exposed to secondhand smoke for just 30 minutes. Chronic active smokers are likely to have coronary artery stenosis and possibly, ischemia (decreased oxygen delivery to the heart). In contrast, there is no possible way that 30 minutes of secondhand smoke exposure can cause coronary artery stenosis or cardiac ischemia. These differences could easily be ascertained through a stress test, electrocardiogram, and/or coronary angiography.

To suggest that 30 minutes of secondhand smoke exposure is as bad for coronary artery function as a lifetime of active smoking is not only a joke, it is also seriously harmful. It really undermines the public's understanding of, and appreciation of, the cardiovascular effects of smoking.

If I were a smoker who had smoked for 40 years and was told that my coronary artery function was indistinguishable from a nonsmoker who walked into a smoky restaurant for 30 minutes, I would be convinced that smoking has essentially no adverse cardiovascular health consequences. I would probably celebrate by immediately lighting up. There would be no incentive for me to quit, since I've basically just been told by an anti-smoking group that my coronary artery function is no different from what it would be if I had never smoked in my life but had merely breathed in some drifting tobacco smoke for 30 minutes.

Can you see how this health claim by the Association for Nonsmokers is every bit as false and misleading and damaging as the fraudulent claims that tobacco companies have put out to the public?

Having given the Association for Nonsmokers the benefit of the doubt, it is still unfortunate that a press release went out stating that only 30 seconds of secondhand smoke causes as much deterioration of coronary artery function as years of active smoking. It truly undermines the appreciation of the cardiovascular risks of smoking and does a disservice to the protection of the public's health.

I would expect that a quick correction and apology would be made for these errors (first, for the 30 seconds; second, for the suggestion that coronary artery function in a smoker is indistinguishable from that of a nonsmoker exposed for a mere 30 minutes).

But for now, the Association for Nonsmokers - Minnesota holds the record for the claim of the least amount of time it takes for secondhand smoke to severely harm you; 30 seconds is going to be hard to beat.

Thursday, October 12, 2006

ANR Criteria Suggest that Helena and Piedmont Studies are Invalid

By criteria set out by Americans for Nonsmokers' Rights (ANR) to determine the validity of studies analyzing the impact of smoking bans, two studies being touted by ANR itself as demonstrating that smoke-free laws immediately and drastically reduce heart attacks are "illegitimate."

According to ANR:

"When handed a tobacco-related study - particularly if it claims that going smokefree hurts business - consider these factors to determine if it is a legitimate study or one funded and created by the tobacco industry. ...

Are sales figures analyzed for at least one year?

To identify underlying trends and fluctuations in the restaurant business cycle's yearly sales, was the study conducted over a sufficiently lengthy period to make the data meaningful? Economic impact studies should include restaurant sales data for several years before a law is enacted, as well as for all quarters after enactment. The economy changes for many reasons: inflation, seasonal variation, and fluctuations due to the weather and other superfluous events. Short-term observations cannot accurately evaluate economic impact. By collecting data for several years, it is possible to identify and quantify these trends and take them into account. An observed decrease in sales data for one or two quarters may simply be a typical downward trend in restaurant sales that occurs every year."

Despite the fact that restaurant sales would be expected to change more rapidly in response to a smoking ban than heart attacks, the Helena and Piedmont studies collected data for only 5-6 months after the implementation of smoking bans in those jurisdictions.

Thus, by ANR's own criteria, the Helena and Piedmont studies are not legitimate. Nevertheless, this hasn't stopped ANR from using those studies as the basis for its claim that smoking bans reduce heart attacks by 30-40%.

The Rest of the Story

Since the Piedmont study only examined heart attacks for 5 months following the implementation of Italy's smoking ban and the Helena study only examined heart attacks for 6 months after implementation of the smoking ban in Helena, neither of these studies comes close to meeting ANR's criterion of needing one year of data following a smoking ban before a legitimate conclusion can be drawn regarding the smoking ban's impact.

Therefore, I guess these studies are illegitimate.

What ANR pointed out about fluctuations in restaurant sales can also be said about heart attacks: "The rate of heart attacks changes for many reasons: medical treatments, seasonal variation, and fluctuations due to other superfluous events. Short-term observations cannot accurately evaluate heart attack trends. By collecting data for several years, it is possible to identify and quantify these trends and take them into account. An observed decrease in heart attacks for one or two quarters may simply be a typical downward trend in heart attack incidence."

Based on ANR's own argumentation, there is very real reason to suspect that the Helena et al. conclusions are invalid. At very least, there is strong reason for caution in interpreting the results of these studies.

However, ANR has gone so far as stating that any suggestion that the conclusions of these studies are premature is hogwash: "The Helena Heart Study demonstrates that even a little exposure to secondhand smoke can be deadly. The study is powerful, and demonstrated the urgent need for smokefree laws to protect the public. So it comes as no surprise that the Helena Heart study has unfairly come under attack by the opposition. The opposition has used unsubstantiated claims to argue the validity of this study. These claims are hogwash."

Yet we are to believe that ANR's attack against a slew of economic impact studies that found negative effects of smoking bans on restaurant sales is not hogwash.

I happen to think that ANR's criticism of these particular studies is valid, but if one is to have any consistency at all, then one must also acknowledge that the "opposition's" (I guess I am the opposition) questioning of the validity of the Helena et al. claims is also legitimate, if not valid.

ANR's statement to the public obviously fails to explain why I have criticized the Helena conclusions, since I support smoking bans and so am not "unfairly" attacking the Helena study because it "is powerful, and demonstrated the urgent need for smokefree laws to protect the public."

By the way, even if one accepted the Helena conclusions as the truth, they still do not demonstrate that "even a little exposure to secondhand smoke can be deadly." The study did not ascertain whether the heart attack admissions occurred among smokers or nonsmokers, so it can draw no conclusions on what the contribution of reduced secondhand smoke exposure was to the observed decline in heart attacks.

I take it that ANR would call me "painfully uneducated" since they link to an American Heart Association "fact sheet" that states that the argument that the observed decline in heart attacks in Helena may be due to random variation is painfully uneducated.

I also take it that ANR, and the American Heart Association for that matter are stating that by making my claims, I am "claiming that [I] alone [am] smart enough to draw a conclusion that none of the statisticians at the British Medical Journal and CDC agree with."

That, my friends, is hogwash. First of all, in claiming that there are alternative explanations for the observed findings in Helena, one is not making any claim about how smart one is. Instead, one is simply making a scientific argument. Second, it is wrong to imply that every statistician at the British Medical Journal and every statistician at CDC has agreed with the Helena conclusion.
The truth is that even the scientists at CDC who argued that 30 minutes of secondhand smoke might precipitate heart attacks questioned the validity of the Helena conclusions, pointing out a number of serious limitations of the study methodology that render any definitive conclusions premature:

"Although the results of the study by Sargent and colleagues are consistent with the literature on the risks of acute myocardial infarction associated with secondhand smoke, the study has some important limitations. Firstly, it contains no data on actual exposures to secondhand smoke among residents or cases, and thus no data on the changes in exposure to secondhand smoke that may have occurred after the policy was implemented. It might be reasonable to assume that levels of important smoke toxins within public places in Helena covered by the ordinance dropped dramatically. This effect has been observed in other locations where similar policies have been implemented, with air quality measurements showing 80-90% declines in public places. Even if such declines also occurred in Helena, some proportion of non-smokers would still have been exposed in their homes, cars, or other enclosed places not covered by the ordinance. Thus, without more data, the proportion of non-smokers in Helena among whom exposures were significantly reduced during the six months that the ordinance was in effect cannot be known.

A second concern is that the geographical isolation of the city, while making this type of study feasible, also resulted in a small number of admissions for acute myocardial infarction. As reported elsewhere, the typical number of acute myocardial infarction events per month before the ordinance was only about six or seven and was highly variable, with the actual number per month ranging from none to about 10-12. Although conservative statistical analyses were applied to these data, due to the small number of events and the lack of data on changes in active smoking, random variation and factors other than secondhand smoke exposure may have contributed to the findings.

Finally, the observed effect (a decline of an average of 16 admissions for acute myocardial infarction for a six month period) was substantially greater than what might be expected. With smokers accounting for 38% of the admissions, we can estimate that about 25 admissions (40*—0.62 = 24.8) were among former and never smokers during the equivalent six month period before the ordinance. Even assuming that the proportion of acute myocardial infarction cases among smokers was fairly constant across time, that all non-smokers were frequently exposed to secondhand smoke in public places, that virtually all this exposure was eliminated by the ordinance, and that all coronary heart disease risk related to this exposure was immediately reversed among non-smokers (that is, that risk dropped from 1.3 to 1.0), the maximum impact on admissions for acute myocardial infarction would be predicted to be about 18-19% (0.30*—24.8 = 7.44; 7.44/40 = 18.6%) during the six months that the ordinance was in effect. Taking all of the above assumptions and issues into consideration, a more conservative estimate of the predicted reduction in acute myocardial infarction events might be 10-15%."

According to ANR, therefore, these CDC scientists are part of the opposition which is attacking the Helena study because they despise smoking bans, and their arguments are unsubstantiated claims and pure hogwash.

I think I am finally beginning to understand ANR's logic here. If a study finds results favorable to the anti-smoking agenda, then it is a valid study and is not subject to any criticism. Any questioning of the results of that study must be based on opposition to smoking bans, and must be funded by or commissioned by the tobacco industry, probably through its front groups. Such criticism is hogwash.

If a study finds results unfavorable to the anti-smoking agenda, then it is junk science, probably funded by or commissioned by the tobacco industry through its front groups, and it needs to be countered, preferably by pointing out to the public that the science on the issue is "crystal clear," and thus not subject to any critique or opposing findings.

It's really too bad that I have been kicked out of the movement. I think I'm really beginning to understand the way that things work. I could have made a great career for myself in the movement, now that I really get it.

Wednesday, October 11, 2006

ANR Calls Helena and Pueblo Junk Science Claims "Crystal Clear Science," While Decrying Economic Impact Studies with Same Methodology

In a press release, Americans for Nonsmokers' Rights (ANR) has concluded that a smoking ban in Pueblo resulted in a 27% decline in heart attacks, even though this decline could well be due to random variation as well as a secular decline in heart attacks that was occurring in Colorado in the absence of smoking bans. ANR called the conclusion that smoking bans in Helena and Pueblo resulted in 40% and 27% declines in heart attacks crystal clear science.

According to the press release: "The [Pueblo] study reaffirms the findings of the recent U.S. Surgeon General'’s Report, "“The Health Consequences of Involuntary Exposure to Tobacco Smoke,"” and the 2003 Helena Heart Study, published in the British Medical Journal, that comprehensive smokefree workplace laws have immediate improvements on community health. ... The Pueblo Heart Study is another report to add to the growing body of scientific evidence illustrating the tangible benefits of smokefree air in the workplace. The science is crystal clear. Smokefree air saves lives and saves money."

The Rest of the Story

I have already explained why I believe that the Helena, Pueblo, and Piedmont study conclusions are essentially junk science.

Briefly, these studies are seriously flawed because they are unable to rule out the reasonable and in fact likely possibility that the observed declines in heart attack admissions were due simply to random variation in the underlying data as well as to a secular trend in declining heart attack admissions during the study period. None of these studies ascertained heart attack admission rates long enough after the implementation of the smoking bans to be able to credibly assess whether it was actually the smoking ban that caused the observed decline in heart attacks or not.

In addition, the claims are scientifically implausible. There is no plausible way that a smoking ban could cause a 40% reduction in heart attacks in six months. Even if all smoking were eliminated completely, we wouldn't expect to observe a 40% decline in heart attacks in six months. So how could a simple smoking ban achieve such an effect?

What is strangely ironic about ANR's rhetoric is that at the same time it uses the Pueblo methodology to conclude that the smoking ban caused a 27% decline in heart attacks, it decries studies using the same methodology which conclude that smoking bans caused an adverse economic impact on restaurants and bars.

Apparently, ANR views the science as "crystal clear" when it supports its agenda, but as "junk science" when it opposes its agenda.

I'm so glad that I did make my exit from ANR, because I would be ashamed to be on the Board of the organization now with this kind of shoddy science coming out of the organization.

It's one thing to support smoking bans on solid scientific evidence of the hazards of secondhand smoke. It's another to widely disseminate shoddy scientific conclusions to the public and base a campaign to promote smoking bans on junk science claims that have no scientific validity.

One could argue that since these studies were published in journals, ANR is justified in touting these shoddy claims. But I would counter that as public health organizations, we have to be capable of evaluating the science ourselves, and of making our own judgments about the validity of the claims we are making.

What is striking to me is the deterioration of the quality of the science coming out of the anti-smoking movement (and I'm not singling out ANR here; it's just one example). Our science has become no better than that commissioned by the tobacco industry. And our standard for judging the quality of science has become whether or not it supports our agenda.

IN MY VIEW: Omaha Smoking Ordinance Doesn't Even Make Public Health Sense

I don't think there are any circumstances in which the 911 emergency response system should be used to report smoking ban violations, but if an anti-smoking group is going to request that citizens use this system to enforce a law, you would think that at least the law would have some solid public health basis to it.

In my view, the Omaha smoking ordinance doesn't even have a solid or logical public health basis to it. In fact, it makes no public health sense at all.

While my readers may have disagreements about whether secondhand smoke is a health hazard that requires government intervention to regulate, I would think that all can agree that whether an establishment allows Keno or not or simulcasts horseracing or not has no bearing on the nature of the secondhand smoke hazard.

If anti-smoking groups in Nebraska think that secondhand smoke is such a critical hazard that we must invoke the 911 emergency system to enforce smoking regulations, then how could they support a law that regulates smoking on the basis of whether Keno or simulcasting are allowed? And if the Omaha City Council thinks secondhand smoke is such a severe hazard that the police department needs to be brought in to enforce smoking regulations, then how can the Council possibly decide that bars and Keno or simulcasting joints don't need to be regulated?

This is hypocrisy.

I was surprised when I actually took the time to read the Omaha ordinance. Based on the anti-smoking groups' invocation of the 911 system to enforce the law, I assumed that these groups must consider secondhand smoke to be a severe hazard to which no one should be exposed. So I was quite surprised to see that the law actually says that no one has to be exposed, unless you work in a free-standing bar or a restaurant or other establishment with Keno or a horseracing or simulcasting facility.

In fact, it seems to me that any restaurant that wants to can get around the smoking ban by simply installing a television that picks up the feed from Horsemen's Park. It wouldn't even need to have betting. By installing a single television with the feed, it becomes a simulcasting facility and is no longer subject to the smoking regulations.

I don't see any public health basis underlying the Omaha smoking ordinance. As such, I don't see how Nebraska anti-smoking groups could support it or how the City Council can, with a straight face, make the public think that they are really doing something in order to protect the public's health. What's going on in Omaha appears to me more like hypocritical political maneuvering than any real public health protection.

And for that, they want citizens to call 9-1-1?

Tuesday, October 10, 2006

Anti-Smoking Group Instructs Public to Call 911 If They See Someone Light Up in Nonsmoking Zone, or If They See an Ashtray in a Nonsmoking Business

A Nebraska anti-smoking group has instructed the public in Omaha to call 911 if they see someone smoking in an area where smoking is prohibited by the new city ordinance, which bans smoking in most workplaces and restaurants, but not in free-standing bars or in restaurants with Keno that applied for their Keno licenses before June 8, 2006. The group – Nebraska GASP – also instructs the public to call 911 if they see an ashtray in a nonsmoking business.

These instructions to the public are linked to by the Nebraska GASP web site, and are actually posted on the web site of the University of Nebraska at Omaha School of Health, Physical Education, and Recreation:

"Q. Who should I call if I see someone breaking the law by smoking, or by having an ashtray in a nonsmoking business?
A. Call the Omaha City Police at 911. Non-emergency calls may be referred to the Telephone Response Squad at 444-5977."

Last week, I reported that Nebraska GASP had publicly supported the request of the Omaha police department to have people call 911 for smoking ban violations, a policy that was opposed by the county's director of emergency services, who warned that this would threaten the emergency system and endanger the public's safety.

Now, it is clear that Nebraska GASP, as well as some sort of anti-smoking contingent within the University of Nebraska, are directly calling upon the public to call 911 if they observe a smoking ban violation, even if that violation is merely the presence of an ashtray.

The Rest of the Story

This is complete insanity. I think the anti-smoking movement has completely gone out of its mind!

Do you mean to tell me that if you walk into a restaurant and you see an ashtray on a table, the appropriate thing to do is to call 911?

I can just see the 911 police dispatcher now:

"Officer W, emergency, 12 Main Street, man running wild with loaded gun in his hand. Officer X, emergency, 3 Oak Street, man unconscious, not breathing. Officer Y, emergency, 2 Pine Street, fire, children in house. Officer Z, emergency, 117 Chestnut, ashtray in restaurant."

I can also imagine the educational lesson given to children in the local elementary schools:

Teacher: OK kids. Today we're going to talk about 911. That's the number you call if you are in an emergency. Everyone say that together. 911.
Kids: 9-1-1
Teacher: What do you do if your mama or papa falls down and isn't moving?
Kids: Call 9-1-1.
Teacher: Good. What do you do if you see a fire?
Kids: Call 9-1-1.
Teacher: Excellent. What do you do if you see someone with a gun on the street?
Kids: Call 9-1-1.
Teacher: Good. And what do you do if you see an ashtray in a restaurant?
Kids: Call 9-1-1.
Teacher: Here's a tricky one. What do you do if you see a smoker in a restaurant?
Kids: Call 9-1-1.
Teacher: And a really tricky one. What if that restaurant has Keno?
Kids: Call 9-1-1.
Teacher: No. Got you. If the restaurant has Keno, you don't call 9-1-1. Only if the restaurant doesn't have Keno do you call 9-1-1.

And here's a conversation I can see between a responsible citizen and the 911 dispatcher:

Responsible Citizen: I am reporting an emergency at the Omaha City Cafe.
911 Dispatcher: What is the emergency?
Responsible Citizen: I see an ashtray.
911 Dispatcher: Is there smoke coming from the ashtray?
Responsible Citizen: No.
911 Dispatcher: Would you consider the Omaha City Cafe to be a stand-alone bar?
Responsible Citizen: Well, there is a bar in here, but it kind of looks like a bar within a restaurant, rather than a stand-alone bar.
911 Dispatcher: OK. So it's not a stand-alone bar. Does the restaurant have Keno?
Responsible Citizen: What's that?
911 Dispatcher: Keno is a game played using a field of numbers from 1 through 80. You can select - or choose Quick Pick - up to 10 numbers in that field. The Lottery's computer randomly chooses 20 winning numbers between 1 and 80 for each game of Keno and displays those winning numbers on the Keno Information Monitor. You win based upon how many winning numbers you match.
Responsible Citizen: Well – yeah – I do see a television screen up above the bar and it has a lot of numbers on it.
911 Dispatcher: Sounds like Keno. OK, on what date did the restaurant apply for its Keno license?
Responsible Citizen: Hold on, I'll check. Hey, bartender. When did you apply for your Keno license?
Bartender: It was last June.
Responsible Citizen: Last June.
911 Dispatcher: Early June or late June?
Responsible Citizen: Hold on. Was it early June or late June?
Bartender: Early June.
Responsible Citizen: Early June.
911 Dispatcher: OK. I'm afraid I'm going to need the exact date.
Responsible Citizen: Sorry -– they need the exact date.
Bartender: Let me check ... (5 minutes later) ... it was June 9.
Responsible Citizen: Are you still there?
911 Dispatcher: Yeah, I'm back. I just had to take a call about a guy who had a stroke. Sorry.
Responsible Citizen: It was June 9.
911 Dispatcher: OK. According to city law, that is indeed a violation of the smoking ordinance. The police are on their way.
Responsible Citizen: What are they going to do?
911 Dispatcher: Arrest the offending ashtray.
Responsible Citizen: And what if the ashtray refuses to go?
911 Dispatcher: It will be charged with resisting arrest.
Responsible Citizen: OK. Thanks for your help. I just hope they don't have to use force. It could get ugly.

Here's a joke:

Question: What do you get when you combine an ashtray and a restaurant without Keno in the city of Omaha?
Answer: A life-threatening emergency.

To analyze this from just one more angle:

Question: Which one of the following is a situation in which Omaha citizens should call 911?
A. You are having trouble breathing and suspect you have pneumonia.
B. You are quite sure that the child living next door is getting repeatedly beaten.
C. Your electricity is out, you've lost your heat, and it's 17 degrees outside.
D. You are a homebound elderly person, there is a blizzard coming, and you have no food in the house.
E. You see an ashtray in a restaurant.

Answer: E. You see an ashtray in a restaurant.

This is the only one of the above situations in which you should call 911. If you are having trouble breathing and suspect you have pneumonia, you should call your primary care physician. Unless you are truly unable to breathe and having a life-threatening emergency, your first line of intervention should be your doctor, not the 911 emergency system. If you want to report child physical abuse, you should call the Department of Social Services or the police department's non-emergency line, unless the child is being beaten at the moment you call. This is important to report, but not a life-threatening emergency. If you lose electricity, call the electric company to report the power outage, not 911. If you are homebound and a blizzard is coming, call a friend, relative, neighbor, or the Department of Senior Services, not 911. If you see an ashtray in a restaurant, this is a life-threatening emergency, and you should call 911 immediately as your first response. Do not call the police department's non-emergency line or the city health department. Call 911.

Here's another question:

Question: You are a responsible Omaha citizen and you notice that a restaurant has provided an ashtray for smokers to extinguish their cigarettes in the entranceway to the restaurant, under a no-smoking sign, and under a placard asking smokers to kindly put out their cigarettes in the ashtray because smoking is not allowed in the restaurant and the establishment wants to comply with the law and protect the health of all their customers and employees. The entranceway is located between the outside doors and inside doors to the restaurant. According to Nebraska GASP and the University of Nebraska, what should you do?

A. Thank the restaurant owner for being law-abiding and for trying his best to comply with the law and for facilitating smokers' cooperation with the law by providing the ashtray in the entranceway.
B. Let the restaurant owner know that the presence of the ashtray constitutes a violation of the city no-smoking ordinance, despite his good intentions.

C. Contact the health department to ask them to remind the restaurant owner that this is technically an ordinance violation and the ashtray will have to be removed.
D. Forget about it. There are more important problems in the world.

E. Call 911.

Answer: E. Call 911.


According to Nebraska GASP and the University of Nebraska, if you see an ashtray in a nonsmoking business, you are instructed to call 911.

Apparently, there are not more important problems in the world.

Well, I can think of just one: the idiocy of some anti-smoking groups and the refusal of the anti-smoking movement to condemn this behavior on the part of their fellow organizations.

Thursday, October 05, 2006

On the Deafening Silence of the Tobacco Control Movement: The Need for Some Moral Courage

The most shocking revelation to me over the last 18 months (the length of time I have been writing this blog) is the complete silence of anti-smoking groups over each and every one of the critical issues I have brought to the movement's attention.

As a veteran of the tobacco wars and of the tobacco control movement, I have pointed out, over the past year and a half, a series of important issues that the movement needs to address. These include the deterioration of our science, unethical tactics being used to promote our agenda (such as disseminating false or misleading information and the use of deception), and the degradation of the agenda itself (such as the embracing of employment discrimination against smokers as an approach to the smoking problem).

But throughout this entire time, not a single U.S. anti-smoking group has joined me in speaking out against the use of deception, the dissemination of findings resulting from shoddy science, the unethical practices of tobacco control groups, or the discrimination against smokers that our movement is now supporting.

I do not believe that the reason for this silence is that not a single anti-smoking group agrees that deception is occurring or that it is wrong or that employment discrimination against smokers is appropriate. One major reason for this silence, I am quite sure, is the fear of retaliation if advocates or groups criticize or question the established dogma of the tobacco control movement.

As I have learned, it is heresy to question. You are sure to be attacked and condemned by your colleagues. You are putting your career at stake by doing so. You, and/or your organization, are risking your continued funding. It is, therefore, perhaps not a surprise that advocates and groups within the movement are afraid to publicly condemn what they know is wrong, inappropriate, or misguided.

The response of the movement to my questioning of some of our tactics, our science, and our agenda has been three-fold. First, ad hominem attacks on me, including questioning of my own motives, character, honesty, and funding. Second, censorship, mainly in the form of expulsion from the tobacco control community's discussion forums. And third, a curious defensive posturing by some that fails to confront any of the issues but seems more like a knee-jerk reflex reaction to the idea that anything negative could be said about any anti-smoking group or anything they are doing.

While I understand the position of these groups and advocates, I do think it is time that they step up (like I have) and display some moral courage. If one group does it, it will be risky, but it will break down some of the barriers that stifle the expression of dissent. If a number of groups do it, then the barriers will come crashing down, as it becomes impractical to attack, censor, and try to discredit when there are multiple dissenters.

I think the time has come. In fact, I think the future of the movement now rests on the shoulders of a number of anti-smoking advocates and groups and hinges on whether they have the moral courage to break out from the groupthink mentality that has overtaken the movement.

Wednesday, October 04, 2006

Campaign for Tobacco-Free Kids Continues to Deceive the American People on FDA Tobacco Legislation

In a September 20 press release, the Campaign for Tobacco-Free Kids condemns Congressmembers who accept tobacco industry contributions, suggests that these contributions are responsible for killing the proposed FDA tobacco legislation last year, and implies once again that Big Tobacco is uniformly opposed to the proposed legislation.

According to the press release: "In light of the recent court ruling, the Tobacco-Free Kids Action Fund called on all political candidates to return campaign contributions from tobacco companies, reject future contributions and pledge their independence from Big Tobacco by supporting legislation that would allow the U.S. Food and Drug Administration (FDA) to regulate tobacco products."

The Rest of the Story

Let's get this straight. The way for Congressmembers to express their independence from Big Tobacco is to stand shoulder-to-shoulder with the nation's leading tobacco company - Philip Morris - and vote to support this company's chief legislative priority: the FDA tobacco legislation.

The suggestion that by supporting the proposed FDA legislation, Congressmembers are pledging their independence from Big Tobacco is clearly implying to the public that this legislation is uniformly opposed by Big Tobacco. There is no way that anyone reading this propaganda could understand from it that in fact, the largest element of Big Tobacco - Philip Morris - actually supports the legislation and is lobbying for its passage.

I view this propaganda piece as being unethical, because it is grossly deceptive and violates the basic ethical principles of transparency and truthfulness. The Campaign for Tobacco-Free Kids is free to support any legislation that they want, but using deception as a tactic to lobby for the passage of this legislation is unethical and inappropriate.

This is not the only deception in the press release. The release, and the accompanying report, claim that tobacco industry campaign contributions are the reason why Congressmembers who opposed the FDA tobacco legislation last year voted against it. What the report tries to hide, however, is the associated fact, disclosed in the report, that the overwhelming source of tobacco company funding spent to lobby Congress was spent by Philip Morris, and in support of the legislation.

The rest of the story is that in 2005, Philip Morris spent $13.6 million lobbying Congress in support of the FDA legislation. This is 7 times higher than the amount spent lobbying Congress by any other tobacco company. In fact, it is nearly twice as much as the amount spent by all of the other tobacco companies (which support the FDA legislation) combined.

So does it not seem disingenuous to suggest that tobacco industry lobbying expenditures are the reason why Congressmembers voted against the proposed FDA tobacco legislation?

Does the Campaign no longer consider Philip Morris to be a part of Big Tobacco? You'd certainly think so reading this propaganda.

The press release is also deceptive in its suggestion that cigarette manufacturers "secretly and significantly increased the levels of nicotine in cigarette smoke between 1998 and 2004". As I have shown with respect to Philip Morris, there were some fluctuations in the nicotine levels but no overall increase. Moreover, none of this was done secretly. The tobacco companies reported these nicotine levels to the Massachusetts Department of Public Health. The changes in nicotine yields were public information.

The truth is that the Campaign for Tobacco-Free Kids, in its propaganda, is being far more deceptive than the tobacco companies in altering the levels of nicotine in their cigarettes.

We need to start recognizing that no matter how noble we believe our cause is (and I don't happen to think that providing special protections for Philip Morris to enlist their support for the FDA legislation is particularly noble in the first place), it does not justify the use of unethical behavior - disseminating deceptive and misleading propaganda to the public - to support that cause.

Tuesday, October 03, 2006

Piedmont Study Methodology is Similar to Studies Showing Adverse Economic Effects of Smoking Bans; Junk Science Cuts Both Ways

A careful examination of the methodology used in the Piedmont study which purported to show that the smoking ban in Italy reduced heart attack admissions by 11% reveals that it is essentially the same as that used by a number of studies, attacked by anti-smoking groups, which found that restaurant smoking bans have an adverse economic impact on businesses.

The Piedmont study compared age-standardized heart attack admission rates of Piedmont residents during the 5-month period February-June 2005, which immediately followed the smoking ban (implemented in January 2005), with heart attack admission rates during the same period (February-June) for the previous 4 years.

The Rest of the Story


Here is a brief review of studies using similar methodology to that used in the Piedmont study, which concluded that smoking bans caused an adverse economic impact on restaurants.

1. Laventhol & Horwath, 1990

Laventhol and Horwath conducted a study that was quite comparable to the Piedmont study in terms of the methodology used to assess the effect of a smoking ban (Laventhol & Horwath. Preliminary Analysis of the Impact of the Proposed Los Angeles Ban on Smoking in Restaurants. Los Angeles: Laventhol & Horwath, 1990).

This study compared restaurant sales in Beverly Hills during a 3-month period (2nd quarter, 1987) following the implementation of a restaurant smoking ban to the comparable period the year earlier (2nd quarter, 1986). As in the Piedmont study, the authors excluded data from the first month in which the ordinance was in effect, considering this to be a transition period.

The authors found a 6.7% decline in restaurant sales in Beverly Hills, which they attributed to the smoking ban. Unlike the Piedmont study, these authors did go to the trouble of including a comparison group in the study. They examined changes in restaurant sales in Los Angeles during the same period and found that there was a 10.3% increase.

2. Masotti & Creticos, 1991

Masotti and Creticos also examined the effects of a smoking ban using nearly the same methodological approach as in the Piedmont study (Masotti L, Creticos P. The Effects of a Ban on Smoking in Public Places in San Luis Obispo, California. Northwestern University and Creticos & Associates, Inc., 1991).

They compared sales tax receipts indicating the level of restaurant sales in San Luis Obispo (California) during a 5-month period (exactly the same amount of time) following the smoking ban's implementation to restaurant sales during the comparable period during the previous year.

Compared to the 3rd and 4th quarters of 1989, there was a drop of 3% and 26%, respectively, in restaurant sales in the 3rd and 4th quarters of 1990 (the smoking ban went into effect during the 3rd quarter of 1990).

Unlike the Piedmont study, a comparison group was included (actually, two). The study finds that there was no corresponding decline in restaurant sales for the same time periods within the county of San Luis Obispo as a whole or in the state as a whole. In fact, there were slight increases in restaurant sales (2.6% and 4.2% for the 3rd quarter and 2.0% and 2.4% for the 4th quarter).

3. Lilley & DeFranco, 1999

Lilley and DeFranco studied the change in the number of bars and number of bar employees in California before and after the statewide bar smoking ban went into effect (Lilley W, DeFranco L. The Impact of Smoking Restrictions on the Bar and Tavern Industry in California. Washington: InContext Inc., October 26, 1999).

The ban was implemented on January 1, 1998. So Lilley and DeFranco compared the number of bars and bar employees on January 1, 1997 to the corresponding figures for January 1, 1999. They reported a 7.4% decline in the number of bars and a 12.7% decline in the number of bar employees, which they attributed to the smoking ban.

As a comparison, the report examined overall retail trade trends, finding that during the same period, retail trade employment increased by 4.2% and total employment was up by 5.7%.

Like the Piedmont study, this report stratified the data to look specifically at effects among the bars which the authors expected to suffer the most from a smoking ban: smaller bars. In fact, they found that the decrease in establishments and employment was most dramatic among small bars with 5-9 employees (17.9% drop in establishments; 16.4% drop in employment).

4. Lilley and DeFranco, 1996

Another study by Lilley and DeFranco examined trends in the number of restaurant jobs in New York City before and after its restaurant smoking ban (Lilley W, DeFranco L. Restaurant Jobs in New York City, 1993 Through First Quarter 1996, and the Restaurant Smoking Ban. Washington, DC: InContext Inc., 1996.).

Compared to January 1, 1993 (prior to the smoking ban), the number of restaurant jobs in New York City declined by 2,779 by the first quarter of 1996 (about one year after the smoking ban went into effect). This represented 4.0% of New York City's restaurant job base. In contrast, the political jurisdictions surrounding New York City gained 1,937 restaurant jobs during the same period, representing 5.0% of the restaurant job base. The paper attributes these changes to the smoking ban.

Conclusion

The rest of the story is that the same methodology relied upon by anti-smoking groups to tout a dramatic effect of smoking bans on heart attack rates has been used to demonstrate a dramatic effect of smoking bans on restaurant sales. But while the latter studies have been condemned by anti-smoking groups and called junk science, the former studies are being used to support widespread public claims.

It appears that the anti-smoking movement judges the quality of science by the nature of its findings. Here, we have a number of studies that used essentially the same methods. The studies which produced results that hurt the anti-smoking agenda were attacked and trashed by the tobacco control movement; yet when studies with essentially the same methodology produced results that support our agenda, we tout those same studies around as proof that our agenda is supported by this science.

In other words, when the science produces favorable results, it is science; when it produces unfavorable results, it is junk.

I'm afraid that there is a double standard here. Our scientific judgment appears to be obscured in a mesh of hypocrisy.

One anti-smoking group's website is devoted to debunking a series of what it claims are invalid studies which reported an adverse economic impact of smoking bans. Interestingly, one of the criteria that the TobaccoScam web site sets forward in determining what makes a "bad" study is the failure to use at least one full year's worth of data. If anything, the need for a full year's worth of data is even more important for a study of changes in heart attacks than restaurant sales, since one would expect that there could be drastic changes in restaurant sales that could occur very rapidly, while changes in heart attack rates would take considerable time to be realized.

Based on the criteria set forth on the TobaccoScam website, the Piedmont study would be classified as a "bad" study, in the category of "Cooking the Books."

In other words, the methods used in the Piedmont study were characterized by anti-smoking groups as being an attempt to "cook the books" and artificially find an adverse economic impact of smoking bans. These methods, however, are apparently rock solid as long as the resulting finding is a favorable one. The criteria set forth on the TobaccoScam web site don't seem to apply to tobacco control studies, only to those conducted by our "opponents."

Also of interest is the fact that many of the above economic impact studies were paid for, or commissioned by the tobacco industry. What this means is that we are essentially using the same techniques that the tobacco companies used to try to demonstrate an adverse economic impact of smoking bans to demonstrate a positive immediate health benefit of these policies.

Are we so biased that our desire to produce results that support our agenda is clouding our scientific judgment enough that we are willing to condemn a study with unfavorable findings but tout around a study of essentially the same methodology with favorable findings?

It appears that the answer is yes. At least I will be forced to assume the answer is yes until I see someone or some group from within tobacco control which is willing to criticize the Piedmont study and others like it, as they did the tobacco industry-sponsored studies which used similar methodology to find an adverse economic impact of smoking bans.

Monday, October 02, 2006

Piedmont Italy Study Becomes the Latest in a String of Junk Science Papers on Effects of Smoking Bans on Heart Attack Admissions

An article published online in the European Heart Journal concludes that a national smoking ban in Italy resulted in an 11% decline in heart attack admissions in the Piedmont region of northern Italy during the first 5 months following its implementation.

The study compared age-standardized heart attack admission rates of Piedmont residents during the 5-month period February-June 2005, which immediately followed the smoking ban (implemented in January 2005), with heart attack admission rates during the same period (February-June) for the previous 4 years. Rates were examined separately for men and women and for persons older than or younger than 60.

Among those older than 60, there was a small increase (5%) in the heart attack admission rate from 2004 to 2005. For those under 60, the heart attack admission rate decreased by 11%.

The actual rates, by year and sex for those under age 60 were:

MEN
2001: 1.21
2002: 1.25
2003: 1.31
2004: 1.35
2005: 1.24

WOMEN
2001: 0.22
2002: 0.22
2003: 0.19
2004: 0.24
2005: 0.19

As a comparison, heart attack admission rates during the 3 months prior to the smoking ban (October-December 2005) were compared to rates during the same period one year earlier. Among those younger than 60, the rate increased by 6%.

The paper concludes that the smoking ban resulted in the observed 11% decline in the heart attack admission rate in Piedmont.

The Rest of the Story

This is an example of what I would consider to be junk science.

To isolate a five-month period during one year following a smoking ban, compare it to the same five-month period during the previous year, observe a decrease in heart attack admissions, and conclude that the decline was due to the smoking ban is not solid science. It is more on line with what I would term pure speculation.

In fact, this is the precise type of methodology that we in tobacco control have attacked as being unreliable in concluding that smoking bans have resulted in a decline in restaurant sales. Tobacco industry commissioned or funded studies, using the same methodology and finding a decline in restaurant sales associated with smoking bans have been blasted by tobacco control groups as being junk science. There is no reason why we should not view studies using the same methodology in the same way, even though the only real difference is that their findings are supportive of, rather than in opposition to, our agenda.

The biggest problem with this study is that it is impossible to rule out the simplest of alternative hypotheses: that the observed decline in heart attack admissions is simply due to random variation in the data. In other words, it is very possible that the rate of heart attack admissions would have declined in the absence of a smoking ban. It is impossible to tell, and it is impossible to even make a reasonably solid judgment in the absence of any presentation of underlying secular trends over any significant length of time and the absence of any comparison group.

A single point does not indicate a trend, and that is really the fatal flaw of this paper. It is entirely possible that the admission rate simply blipped up a little in 2005 and that in 2006 it will go back down a little. Or that the blip up in 2005 is simply a reflection of an overall trend of decreasing heart attacks during this time period that is not specific to Italy. There's just no way to know.

If you simply look at the data, you'll see that concluding that there is a substantial decline in the heart attack rate due to the smoking ban is unfounded. In fact, if you graph out the data for women under 60, it actually appears that the observed decline in admissions in 2005 is due solely to the fact that there was a slight upward blip in 2004.

Based on the heart attack admissions rates among Piedmont women under 60 during the months of February-June from 2001-2003, the observed heart attack admission rate for 2005 should have been 0.16. Instead, it was 0.19. Does this mean that the smoking ban increased the rate of heart attacks among Piedmont women?

The truth is that the observed rate of heart attacks among Piedmont women, ages 60 and younger, during February-June 2005 is exactly the same as it was during the same period in 2003. This doesn't bode well for a conclusion that there was a substantial decline in heart attacks due to the smoking ban.

The complete absence of a comparison group is another fatal flaw. One simply has no idea what the underlying secular trend in heart attacks was from 2004 to 2005 in the overall region. Thus, it is impossible to attribute any observed decline in the rate to the smoking ban, rather than to a secular trend that would have been observed anyway, even in the absence of the smoking ban.

But the most peculiar aspect of the paper is that the authors felt compelled to stratify their results by age. This is in contrast to any of the previous papers on this topic. So it is somewhat surprising to find this stratification in this paper.

Unfortunately, a closer analysis of the data suggests the reason why the data may have had to be stratified. If one examines the total number of heart attack admissions in Piedmont during the study period, one observes what appears to be an increase in heart attacks, with a 2% increase from February-June 2004 to 2005, the precise comparison period used to draw the study's major conclusion.

Is it possible that in the original analysis of the data, the paper found this 2% increase, and that the idea of stratifying the data occurred only after the failure to find a decrease in heart attacks when the question was examined in the standard way that it has been looked at in prior research?

The bottom line, that cannot be altered with data manipulation, is that using the same standards of analysis that the authors of the Helena, Saskatoon, and Pueblo studies used, the Piedmont study has demonstrated that the implementation of the smoking ban was associated with a 2% increase in heart attacks. The number of heart attacks from February-June 2005 increased from 3581 to 3655.

The paper argues that the fact that the decline in heart attacks was found only among those under age 60 is evidence that the conclusions are valid. But if you do enough stratification, you're bound to find some group in which heart attacks declined. To me, this severely weakens, rather than strengthens, the study's conclusions. The fact that the data had to be manipulated far beyond what has been done in previous research in order to find what appears to be the desired effect greatly weakens the study's conclusions.

While the paper tries to rationalize its decision to stratify on age based on the supposition that younger people would be more likely to be most affected by a smoking ban, this decision doesn't jive with the supposed conclusions from Helena and Pueblo. In addition, one could make the argument that if secondhand smoke reductions are going to cause a reduction in heart attacks, this is going to occur among those people with the most severe and brittle coronary artery disease, among whom a slight trigger, such as secondhand smoke, could cause an acute coronary event. But this group is likely to be somewhat older or at least to include older as well as younger individuals.

Another curious quirk of the research, which also comes out of the blue (not done in any of the previous studies on this issue) is the exclusion of most of the data collected in the research. The basic comparison that is made consists only of data from February-June of 2005 versus the same 5 months during 2004. However, the study collected data on heart attacks during the remainder of 2005 and during all the months of the previous 4 years. Why weren't all of these data used to establish the seasonal and secular trends and random variation in the data and then to examine the complete 2005 heart attack pattern in light of this? Why would one jump to a premature conclusion before even observing the pattern for the entire year?

Perhaps the most interesting aspect of the paper is its conclusion that a reduction in secondhand smoke exposure among nonsmokers caused by the smoking ban could cause an 11% reduction in heart attacks, while the effects of the ban on reducing active smoking could only cause a 0.7% reduction in heart attacks.

As I stated earlier, one would expect the effects of any reductions in active smoking due to smoking bans to have a more substantial effect on heart attacks than any reduction in secondhand smoke exposure (note that active smoking causes far more heart attacks than secondhand smoke). So what the paper has really shown is that one would only expect a very small reduction in heart attacks attributable to a smoking ordinance within a short period of time.

There is another reason why I think one would not expect to see a drastic effect of reduced secondhand smoke exposure on heart attacks within a several month period. In order to expect such an effect, one would have to postulate that secondhand smoke triggers acute cardiac events in persons with severe coronary artery disease, who are basically time bombs waiting to go off. In other words, the slightest insult to the system is capable of triggering a heart attack.

Well, if you eliminate secondhand smoke exposure, these people are still going to be susceptible to any other trigger. Eating a high-fat meal causes endothelial dysfunction, and might also trigger a cardiac event. So it is not clear that simply eliminating secondhand smoke exposure would prevent these individuals from suffering heart attacks.

It seems to me that we've set ourselves up for a giant failure. We've now led to the world to expect that we're going to be able to demonstrate drastic and immediate reductions in heart attacks following smoking bans. But I don't think such an effect is plausible. So when more carefully conducted studies, with longer follow-up periods, are finally conducted, they are most likely not going to find such effects. Then, instead of simply reasoning that one wouldn't expect dramatic effects, the public is going to conclude that the whole thing was a big hoax. By making this the cornerstone for our arguments in support of smoking bans, when this thing is shown to be untrue, the whole building might come crumbling down.

Although I've been quite harshly critical of the conclusions of the Helena and Pueblo studies, the Piedmont study is by far the weakest of the three. There is no comparison group, it fails to analyze all the available data, it is forced to stratify the data in order to find an effect, and it truly uses only one data point following the implementation of the smoking ban.

The study actually finds an increase in heart attacks from 3581 to 3655, a 2% increase, that is associated with the implementation of the smoking ban. Thus, in some ways, this study actually disproves the conclusions from Helena and Pueblo. Yet the data are manipulated in a way that tries to make it appear that there was a dramatic decline in heart attacks. Even accepting the data manipulation, this conclusion is completely unfounded.

The Piedmont study is an example of junk science and as much as we in the tobacco control field would like to accept its conclusions, doing so is going to make us hypocrites, destroying our credibility.

Anti-smoking groups and researchers need to discredit this study's conclusions in order to make it clear that we have some scientific integrity and that as much as we would like to see dramatic effects from our interventions, we will not disseminate information to the public to support our agenda unless it is based upon solid science.

Sunday, October 01, 2006

Anti-Smoking Group Supports Use of 9-1-1 System to Enforce Omaha Smoking Ban

According to an article on the WOWT (Omaha NBC affiliate) web site, a Nebraska anti-smoking group is supporting the use of the 9-1-1 emergency system to enforce the new Omaha smoking ban, which goes into effect tomorrow. The group - Nebraska GASP - wants people to call 911 if they see someone smoking somewhere they shouldn't be.

The Omaha police department has asked the public to help enforce the smoking ban by calling 9-1-1 to report violators. When asked to comment about this, Nebraska GASP president Mark Welsch apparently told WOWT that "he agrees with OPD's directive to call 9-1-1."

The county's emergency director has warned that the use of 9-1-1 to report smoking ban violations threatens the emergency system, endangering the public's safety. He has asked people not to call 9-1-1 to report seeing someone smoking in a place where smoking is prohibited by the city ordinance.

The Rest of the Story

I guess I was right when I argued that the tobacco control movement had run amok. This is about as amok as you can be: asking people to call 9-1-1 to report smoking ban violations.

The ordinance itself does not mention anything about 9-1-1, so I'm not blaming anti-smoking groups for acting improperly with respect to the ordinance itself. But it seems quite clear that Nebraska GASP, arguably the most prominent anti-smoking group in the Cornhusker State, supports the use of the state's emergency response system to address smoking ban violations. It seems that this anti-smoking group views someone lighting up as an emergency.

The extremist element of the tobacco control movement is out of control. In this particular example, the lack of reason and restraint being exercised actually threatens the public's safety. If the 9-1-1 system gets inundated with calls about potential smoking ban violations, it could interfere with emergency personnel's ability to respond to bona fide emergencies.

How would like to call 9-1-1 because you're suffering a heart attack but experience a delay in an ambulance getting to you because the system was tied up with calls from people ratting on smokers who lit up in public?

While the smoking violation complaints to 9-1-1 would only come in as a Priority 3 call (to which police officers respond only when they have time), it would undermine the police department's ability to undertake important proactive police work. And if too many people called in, it could tie up the system, delaying response times. The police would have to respond, at some point, to these calls, and a substantial amount of police officers' time could be tied up.

I always thought that smokers' rights groups were exaggerating when they complained about smoking bans representing the establishment of the smoking police. But that is precisely what Nebraska GASP is trying to establish in Omaha.

Mishegas like this is eventually going to convince the public that we are simply a bunch of fanatics. Ultimately, it's going to undermine our effectiveness in promoting the public's health.