The Rest of the Story: Tobacco News Analysis and Commentary

President Obama No Longer Eligible for Employment at Susquehanna Health Systems

2009-11-20T06:35:00.001-05:00

According to a new policy that goes into effect on January 1, 2010, smokers, smokeless tobacco users, and occasional customers of a hookah bar need not apply for employment with Susquehanna Health Systems, a health care company in the Williamsport, Pennsylvania area.

According to an article in the Williamsport Sun-Gazette: "To further expand its smoke-free environment, Susquehanna Health has adopted a new policy that prohibits the hiring of smokers and other tobacco users. Health system officials and legal experts noted the policy, to take effect Jan. 1, is perfectly legal under state law. It affects every position within the health system."In Pennsylvania, tobacco users are not a protected class under the law," explained health system spokeswoman Tracie Witter. "So prohibiting the hiring of tobacco users is not discrimination."

"Everyone who seeks health system employment must apply online, Witter noted. At that time, they are made aware of the policy. "We have been testing for drugs. We are adding a nicotine component," she said." ...

"We are aware that we may lose some top candidates as a result of this policy," Witter said. "It's really a demonstration of our commitment to promote healthy behaviors."

"The local chapter of the American Cancer Society endorsed the new policy. Announcement of the health system's policy coincides with today's annual American Cancer Society "Great American Smokeout," which embraces smoke-free lifestyles. "As a regional health system and a leader in both medical education and community health improvement, we have an important obligation to practice the healthy behaviors we promote to the general public and to our own employees," said Susquehanna President and CEO Steven P. Johnson."

The Rest of the Story

Let's first get one thing straight. The Susquehanna Health systems spokesperson is dead wrong when she states that: "tobacco users are not a protected class under the law, so prohibiting the hiring of tobacco users is not discrimination."

It's not illegal discrimination, but it sure as heck is discrimination.

The spokesperson herself essentially admits this later on in the article when she acknowledges that she is "aware that we may lose some top candidates as a result of this policy." She is thus stating that the policy represents a systematic exclusion of a group of people from employment upon a criterion that is not directly related to the qualifications for employment. That is, in fact, the definition of employment discrimination.

At least the lawyer gets it right when he defends the legality of the policy on the grounds that while it is discrimination, employment discrimination against smokers is legal: "It is not illegal to discriminate against a smoker. The reason for that is an institution may discriminate against smokers."

That reasoning seems a little circular, but the point is that it is well established that this policy is precisely employment discrimination.

The policy affects every position in the health system, so if President Obama were to apply for the position of Chief Executive Officer of the Susquehanna Health System (please refrain from jokes that with the public option, that's what he is actually doing), he would not be eligible and in fact, his application would not even be considered.

The current CEO of the health system defended the policy, stating that he has an obligation to ensure that the employees of the company practice the healthy behaviors that they promote.

OK, then, is the CEO also going to refuse to hire obese people, since obesity is arguably the number two public health problem (some would say number one) behind smoking and no one would disagree that the Susquehanna Health System should be discouraging obesity? Is the CEO also refusing to hire people who eat crappy diets or who fail to get adequate exercise? Of course not. This is not a policy which comes from a sincere desire to make sure that employees are adhering to healthy behavior; it is a policy which comes from a desire to punish smokers by denying them employment.

If this were a sincere effort to make sure that employees' behaviors are not inconsistent with the advice they are giving to patients, then applicants whose nutrition is poor, who eat too many calories, or who don't get enough exercise would also have to be excluded from employment.

It is disappointing, but not surprising, to see that the American Cancer Society is supporting this policy. Since when did supporting and promoting employment discrimination become a public health objective? It is one thing to embrace healthy lifestyles. It is quite another to systematically punish and discriminate against people who do not adhere to such a healthy lifestyle in one way or another.

Physicians Group Supports Electronic Cigarettes for Smoking Cessation and Challenges Opponents to Justify their Condemnation of the Product

2009-11-19T07:37:00.000-05:00

The American Association of Public Health Physicians (AAPHP) has challenged opponents of electronic cigarettes to justify their condemnation of this product given that the FDA's study of these devices found that they contain only miniscule levels of carcinogens, compared to the high levels present in traditional cigarettes.

According to a press release issued earlier this week: "In July of this year, the Food and Drug Administration released a study that condemned electronic cigarettes as an unsafe alternative for smokers, but not all physicians are convinced that the study was accurate or even completely transparent to the tax payers that fund them. "We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes," says Joel L. Nitzkin, Chair of the American Association of Public Health Physicians Tobacco Control Task Force in a letter to the FDA."

"The letter specifically targets the new tobacco legislation that passed through Congress this summer which gives the FDA power to regulate tobacco products in the United States and notes that the success rate of current smokers who attempt to quit by using pharmaceutical aids is as low as 5%. Making smokers more aware of less harmful alternatives, snus and e-cigarettes included, could significantly reduce the amount of smokers who die due to tobacco-related illnesses."

"The message the AAPHP is sending to the FDA is a clear one and that is that electronic cigarettes are not the wildly dangerous alternatives that they have been portrayed as in news publications and on television, but perhaps one of the best products available for current smokers to switch to. Only time will tell if the FDA will retract their July study in favor of a more complete one or if smokers will continue to be limited to only products offered by big tobacco or big pharma with no explanation."

The Rest of the Story

I applaud the AAPHP for taking this strong and science-based stand, which contrasts with the ideology-driven positions that have been taken by a number of anti-smoking groups that have called for the removal of electronic cigarettes from the market, despite clear evidence of their utility in helping smokers quit and their relative safety compared to cigarettes. As I have mentioned previously, every one of these anti-smoking groups, it turns out, has received funding from pharmaceutical companies and thus have a conflict of interest -- none have disclosed this conflict.

In contrast, the AAPHP position is based not on pure ideology, but on the science, which clearly indicates that electronic cigarettes are a far safer alternative to regular cigarettes and that they appear to be effective in helping highly resistant smokers to quit successfully.

The anti-smoking groups' condemnation of electronic cigarettes is based largely on the FDA's laboratory findings, which actually indicated that e-cigarettes are much safer than regular ones because they contain miniscule levels of carcinogens, while cigarettes contain very high levels of a large number of carcinogens. The level of tobacco-specific nitrosamines is reduced by a factor of up to 1400, indicating a substantial degree of relative safety compared to smoking.

Taking electronic cigarettes off the market is the worst single thing we could do to harm the public's health. Hundreds of thousands of vapers would be forced to return to cigarette smoking and they would therefore suffer a deterioration in their health. How is that a good thing for the public's health? So far, none of the anti-smoking groups have answered this question.

Another thing that none of the anti-smoking groups have done is to disclose their conflicts of interest with Big Pharma, a failure which I believe is unethical. Financial interests in pharmaceutical companies which rely upon smoking cessation drugs for substantial profits are quite relevant to policy regarding e-cigarettes because these products represent a huge threat to the financial well-being of these companies. E-cigarettes represent a huge potential threat to Big Pharma, because they appear to be much more effective than pharmaceutical smoking cessation products.

A final thing that none of the anti-smoking groups has done is to meet my challenge of naming even one specific hazard that e-cigarettes likely pose to vapers. While the damage that would be done to the health of huge numbers of vapers if e-cigs are taken off the market is definite, the health damage that is supposedly being done to vapers from using e-cigarettes is purely speculative and completely hypothetical.

The anti-smoking groups don't appear to want to address the specific scientific issues, probably because they have little ground upon which to stand. Instead, they insist on diverting the issue to talk about anti-freeze, children shelling out $90 to buy e-cigarette kits, and dangerous carcinogens present in e-cigarette cartridges (without mentioning that the levels of these carcinogens are trace levels, and orders of magnitude lower than in cigarettes, confirming their relative safety).

When groups make national policy recommendations without a willingness to actually address the science, you know we've got a problem. Never is that more apparent than with the issue of electronic cigarettes.

San Francisco to Consider Legislation to Limit to 385 the Number of Stores that Can Sell Tobacco

2009-11-18T08:11:00.000-05:00

According to an article in the San Francisco Examiner, San Francisco will soon consider legislation that would limit to 385 the number of stores in the city allowed to sell tobacco products. The proposal is intended to protect the public's health by limiting tobacco exposure to children.

According to the article: "An initial proposal imposes a cap of 35 permits for each of the 11 supervisor districts — 385 total in The City. That is more than a two-thirds reduction from the 1,097 stores currently selling tobacco products citywide. The proposal would not take away permits from businesses, but it would reduce them through attrition until there are no more than 35 per district. Also, owners would not be able to transfer the permits when they sell their stores, said Janet Clyde, a commissioner in the Office of Small Business. The proposal might limit options for smokers, but it would also limit tobacco exposure to children, said Matt Rosen, senior director of community programs for the Youth Leadership Institute. The institute wrote the legislation and is receiving guidance from Supervisor Ross Mirkarimi and the Department of Public Health. The legislation is still being vetted and has not been endorsed by a supervisor. “[Children] can see advertising,” Rosen said. “They can see stores that are visibly selling tobacco and other kinds of products that aren’t very good for them.” The Department of Health says limiting permits would be an extension of its 'commitment to public health.'"

The Rest of the Story

This is the latest in a series of proposals coming out of San Francisco that make it appear policy makers are truly concerned about the devastating effects of tobacco, but which actually accomplish nothing.

The first in the series was the city's ban on tobacco sales at pharmacies......except, of course, pharmacies located in box stores (like Costco) and supermarkets. What sense does it make to prevent cigarettes from being sold in your corner pharmacies, but allow them to be sold in big box stores and supermarkets? Clearly, this policy is not going to curtail the sale of cigarettes. Instead, it will merely re-distribute the income from cigarette sales from small, local businesses to large national chains. Hardly a measure that has anything to do with public health protection. But policy makers and anti-smoking groups are touting this policy to make themselves look (and feel) good. Nothing but window dressing.

It's also terribly inconsistent and hypocritical. If cigarettes are so bad that they should not be sold in corner pharmacies, then why aren't cigarettes so bad that they shouldn't be sold at Costco or in supermarkets? Obviously, this measure isn't about public health protection, it's about being political cowards and trying to achieve political gain without having to actually take a principled stand.

Now we have a similar proposal: cigarettes are so bad and their sale exposes children and promotes tobacco use. So what are we going to do about it? Get rid of the sale of cigarettes in San Francisco stores? No, of course not. Instead, we're going to set an arbitrary limit of 385 stores that can sell tobacco.

What the crafters of this proposal are basically saying is: "It's only a problem if more than 385 stores in San Francisco sell cigarettes. As long as we limit the number of stores that sell cigarettes to 385 or less, then everything is fine. There's no need to protect the kids that live around those 385 stores from the sale of cigarettes, just the kids who would live around the 386th store."

This is absurdity. It makes no sense. If there is a public health justification for banning the sale of tobacco products in San Francisco, then ban it. If not, then don't. But to pretend that arbitrarily setting the number of tobacco outlets at 385 is some sort of public health measure is insane. It does nothing to prevent the sale of cigarettes, which will certainly remain readily available with 385 outlets in the city.

Do you mean to tell me that if there 386 stores that sell cigarettes in San Francisco, there is a major public health problem, but if we get that number down to 384, we have addressed that problem?

I just don't understand this type of reasoning. What are these folks thinking?

The rest of the story is that limiting the number of stores in San Francisco that sell cigarettes to 385 is not going to have any impact on smoking and the policy therefore does not protect the public's health. As such, it represents an unjustified intrusion on private business and is therefore an arbitrary and inappropriate public policy. If advocates want to work in their communities and try to limit the sale of tobacco, that is fine. It serves an educational purpose and allows the community to mobilize around the issue. But a legislated mandate on the number of stores of a given type is not justified unless there is evidence that it would serve a substantial government interest, like protecting the public's health. Cutting the number of tobacco-selling stores from 1097 to 385 is not going to have any impact on smoking in San Francisco. Cigarettes will remain readily accessible.

An unfortunate aspect to this story is that this senseless proposal is being spearheaded by a youth leadership institute that is being funded, in part, by taxpayer money (the San Francisco Department of Health) and in part by the American Legacy Foundation, which is supposed to be "building a world where young people can reject tobacco," not "building a world in which young people are subjected to no more than 35 tobacco outlets per city district."

I don't understand what they are teaching these youths. From what I can see, it's something like: "If you see a severe public health problem, pass a law that puts arbitrary limits on the problem and interferes with business in a way that won't actually have any impact on the problem, but will make it look like you are doing something."

They're not preparing these youths to be leaders. What they're preparing them to be is the politicians and, I guess, anti-smoking practitioners of the future.

Birmingham East and North Primary Care Trust Forced to Remove Distasteful Anti-Smoking Ad

2009-11-17T08:18:00.003-05:00

The Birmingham East and North NHS Trust was forced to remove an anti-smoking ad after several groups and individuals - some of whom are Rest of the Story readers - filed a compliant against the advertisement, arguing that it was not only offensive to smokers but that it promoted abuse of smokers.

The commercial depicts a smoker being brutally beaten by an invisible assailant. He is bleeding profusely and viciously abused. The message of the commercial is supposed to be that if you smoke, you are giving your body a physical beating.

According to its press release: "Freedom2Choose lodged a complaint against the material and upon consideration, the NHS Trust has agreed to remove it from all venues within the next two weeks. Phil Johnson, pub and club liaison officer of Freedom2Choose states, “I am thrilled about this decision as I have had several pub and club clientele contacting me and informing me that they had been abused as result of this material.” Freedom2Choose will actively campaign against the abuse and hatred that individuals continue to suffer as a result of modern anti-smoking techniques."

The Rest of the Story

While it is commendable that the NHS Trust responded positively and definitively by removing the ad, it should never have seen the light of day in the first place.

What would possess a public health agency to put out an advertisement that graphically depicts physical violence upon a smoker?

Can you imagine a public health group putting out the same ad about obesity? I doubt it. I think if a group was previewing a commercial which depicted an obese person being physically beaten, they would immediately realize that the ad was distasteful and that it sends an unintended message. That the same ad - except with a smoker instead of an obese person - apparently did not evoke the same sense in the NHS Trust suggests that abuse of smokers has become normalized to the point that some anti-smoking groups are subconsciously promoting violence against smokers.

When I see a story like this one, it makes me realize just how stigmatized smokers must feel. It explains much of the anger that many smokers have against the anti-smoking groups. I share that anger. And while I differ with groups like Freedom2Choose on the issue of workplace smoking bans, I support their efforts in campaigning against the abuse and hatred that many smokers continue to suffer as a result of increasingly extremist anti-smoking techniques.

Beware the Adverse Effects of Cigarette Taxes on Kids: Study Suggests Anti-Smoking Groups Should Re-Think Their Knee-Jerk Support for Tax Increases

2009-11-16T05:57:00.002-05:00

A study published last year in the Archives of Pediatrics and Adolescent Medicine reports that the costs associated with smoking lead to food insecurity among children living in lower-income households with one or more smokers present (see: Cutler-Triggs C, Fryer GE, Miyoshi TJ, Weitzman M. Increased rates and severity of child and adult food insecurity in households with adult smokers. Archives of Pediatrics and Adolescent Medicine 2008; 162:1056-1062).

According to the study: "Food insecurity was more common and severe in children and adults in households with smokers. ... At multivariate analyses, smoking was independently associated with food insecurity and severe food insecurity in children (adjusted odds ratio, 2.0; 95% confidence interval, 1.5-2.7, and adjusted odds ratio, 3.1; 95% confidence interval, 1.4-6.9, respectively) and adults (adjusted odds ratio, 2.2; 95% confidence interval, 1.6-3.0, and adjusted odds ratio, 2.3; 95% confidence interval, 1.4-3.7, respectively). Conclusions: Living with adult smokers is an independent risk factor for adult and child food insecurity, associated with an approximate doubling of its rate and tripling of the rate of severe food insecurity."

The paper posits that the major reason for this finding is the high expense associated with cigarettes and the fact that spending on cigarettes makes it less possible to spend an adequate amount on food: "In the United States in 2005, an estimated $82 billion was spent to purchase cigarettes, with the average price of a pack of cigarettes being more than $4.38. Families with low income, in general, are more likely to experience food insecurity, spend less on food, and spend a larger percentage of available money on tobacco compared with more affluent families. In developing countries such as Bangladesh, China, and Bulgaria, tobacco expenditures crowd out expenditures for food, health care, and education. While the available data do not enable us to examine whether this is the mechanism behind the findings presented herein, it seems plausible."

The article goes on to explain the consequences of food insecurity for children: "Children who experience food insecurity are at higher risk for cognitive and psychosocial disability, poorer quality of life, and higher rates of suicidal ideation. They have lower scores on standardized academic tests, miss more days of school, and have more difficulty getting along with others. They also have poorer overall health, higher lead levels, increased rates of iron deficiency, and more emergency department use and hospitalizations."

The Rest of the Story

According to the Campaign for Tobacco-Free Kids, which has never met a cigarette tax increase proposal that it hasn't liked, these policy measures are a win, win, win solution that benefits everyone involved. The Campaign argues: "Increasing cigarette taxes is a WIN, WIN, WIN solution for governments — a health win that reduces smoking and saves lives; a financial win that raises revenue and reduces health care costs; and a political win that is popular with the public."

The present research suggests that the Campaign's reasoning is flawed, and that there may be substantial LOSERS from cigarette tax increases: namely, the children and families of smokers who do not quit smoking after a tax increase, and thus who spend more money on cigarettes and less on food, plunging their kids and families into more severe food insecurity with its associated adverse effects.

The Campaign's perspective has been too simplistic. It just isn't true that everyone wins with a cigarette tax increase. While those who cut down or quit smoking do benefit from the tax policy and will see health benefits, for those who do not quit or cut down, especially those of lower income, the policy will likely have significant adverse effects due to its exacerbation of existing food insecurity.

In an accompanying commentary, Dr. Frank Chaloupka notes: "Significant increases in cigarette and other tobacco product excise taxes are widely considered the single most effective policy option for reducing tobacco use. The findings of Cutler-Triggs and colleagues, however, might raise concerns about higher taxes worsening food insecurity in low-income smoking households as these households divert more of their incomes from spending on food to spending on cigarettes in response to the resulting higher cigarette prices."

It is time, I believe, that anti-smoking groups acknowledge these possibly adverse consequences of cigarette tax increases.

The way to ameliorate this problem is to allocate revenues from the tax increase specifically to smoking-related causes, including treatment for smoking-related diseases, and to earmark a substantial proportion of the revenues to benefit low income communities. With these features, a cigarette tax increase can still be an equitable policy.

But without allocating revenues for these specific purposes, cigarette tax increases are no longer equitable and to be sure, there are losers as well as winners. With the current state budget crises, many states are looking to cigarette tax increases to raise revenues and balance their budgets. Most anti-smoking groups are supporting these tax increases, even though the money raised will not be allocated to smoking-related programs and in many cases, will not be earmarked for low-income communities. These policies will have big losers, and for that reason, I believe anti-smoking groups must re-assess their knee-jerk support for such policies.

In an article regarding this research that was published last year on the Health News web site, Action on Smoking and Health offered its own suggestions for how to deal with the above problems.

Its first solution? Treat smoking around children as a form of child abuse and require doctors to report parents who smoke at home in the presence of their children.

Its second solution? Promote malpractice lawsuits against physicians who do not provide effective smoking cessation treatment (i.e., pharmaceuticals) for their smoking patients.

I have previously criticized each of these policy proposals:

Click here for my criticism of ASH's suggestion that smoking around children should be treated as a form of child abuse.

Click here for my criticism of ASH's suggestion that doctors who fail to prescribe pharmaceuticals for their smoking patients should be prosecuted for malpractice.

One final point about the Health News article: It makes the ridiculous assertion that: "exposure to second-hand smoke can cause nicotine withdrawal symptoms in non-smoking family members including sleep disturbances, anxiety, depression, and concentration difficulties." The levels of exposure to nicotine associated with secondhand smoke exposure are extremely low and I am not aware of any scientific evidence suggesting that these low levels are enough to produce nicotine dependence in nonsmokers.

It's not clear where the writer got this notion, but it certainly wouldn't surprise me if she got it from ASH or another anti-smoking group.

The rest of the story is that cigarette tax increases are not necessarily a win, win, win proposition. If not implemented properly and with attention to principles of equity, there can be substantial losers. If those losers turn out to be children who are forced into more severe food insecurity because of these policies, then anti-smoking groups stand responsible for those adverse consequences. Thus, these groups must end their uniform and thoughtless rhetoric and address these concerns directly. The days of knee-jerk support for any and all proposals to increase cigarette taxes - to fund any program under the sun - must end.

(Thanks to Ladyraj and Harry for the tips).

Federal Court Denies Request for Injunction Against Modified Risk Provisions of FDA Tobacco Law, But Suggests These Provisions are Unconstitutional

2009-11-12T08:25:00.000-05:00

Last week, a U.S. District Court in Kentucky denied the tobacco companies' request for an injunction against the modified risk tobacco product (MRTP) provisions of the FDA tobacco law. This does not throw out the tobacco companies' (i.e., the plaintiffs') complaint about these provisions, but it does mean that these provisions will remain in force pending the outcome of the case.

While anti-smoking groups painted this as a huge victory against Big Tobacco, a close reading of the actual court decision reveals that the Court actually indicates the high probability that the modified risk provisions of the law are unconstitutional because they represent an unconstitutional prior restraint on tobacco company speech, by virtue of the law's failure to put a time limit on the FDA's review of requests to market modified risk products.

As the United States District Court decision explains:

"the Plaintiffs argue that the MRTP provision is an unconstitutional prior restraint. To a limited extent, the Court agrees. By requiring applicants to submit “proposed advertising and labeling” and “sample product labels and labelling” with their applications to market modified risk tobacco products, 21 U.S.C. § 387k(d)(1), (5), the MRTP provision operates as a prior restraint by holding that speech captive and effectively “compel[ling] [Plaintiffs’] silence” until the FDA completes its review." ...

"Under the MRTP provision, tobacco manufacturers must submit not only the would-be modified risk product but any “proposed advertising and labeling” and “sample product labels and labelling” to the FDA for review. 21 U.S.C. § 387k(d)(1), (5). Thus, any such proposed speech about a modified risk tobacco product is effectively silenced until the FDA issues a decision. Because this is so, the reasonable time limit safeguard is necessary to satisfy the “principle that the freedoms of expression must be ringed about with adequate bulwarks.” Bantam Books, Inc. v. Sullivan, 372 U.S. 58, 66 (1963). At this point, such a time limit is missing. While Congress has charged the FDA with “establish[ing] a reasonable timetable for the Secretary to review an application under this section,” it has given the FDA two years to come up with one. 21 U.S.C. § 387k(k)(F). The Court thinks it likely that this two-year delay is unconstitutional given that certain portions of the MRTP provision have been in effect since June 22, 2009."

The Rest of the Story

The District Court clearly believes that the modified risk tobacco products provision of the FDA tobacco law is unconstitutional because it represents an impermissible prior restraint on tobacco company speech regarding these products. It is an impermissible prior restraint because there is no time limit to safeguard against an undue interference with the freedom of speech.

I should emphasize that this is one of the challenged provisions of the law that I thought was least likely to succeed. The provisions which I think are most likely to be found unconstitutional are the advertising restrictions, particularly the ban on cigarette advertising within 1000 feet of schools, and the restriction on truthful speech of companies regarding the fact that the FDA regulates and approves tobacco products and that cigarette companies are in compliance with strict FDA standards.

Now it appears that there is a chance that this 3rd provision of the law may also be found unconstitutional, at least as to the absence of a time limit on the FDA's consideration of modified risk tobacco product applications.

Either way, it is clear that the anti-smoking groups are deceiving themselves by thinking that the FDA law is not without constitutional problems. And they are deceiving their constituents and the public by asserting that the full range of advertising and speech restrictions in the law are going to see the light of day.

Hertfordshire Man Denied Surgery to Repair Broken Arm Because He Smokes

2009-11-11T09:37:00.004-05:00

According to an article in the Daily Mail, a Hertfordshire man with a severe disability due to a badly fractured arm has been denied surgery to repair the arm because he smokes.

The man is a plumber who is unable to work due to the injury, which he suffered 10 months ago after falling down the stairs. He was treated immediately with a plaster cast but the repair was unsuccessful because the bones were too far apart. It was determined that he needs an operation to insert a metal plate to properly repair his broken humerus.

An operation was scheduled in May 2009 to perform the appropriate repair; however, the surgery was canceled because the patient failed to follow the surgeons' advice to quit smoking.

Nick Carver, the chief executive of the East and North Hertfordshire NHS Trust, stated: "In canceling Mr Eeles' two operation dates, our surgeons were acting on clinical grounds only. If they are guilty of anything, then it is of having the best clinical interests of their patients at heart."

The Rest of the Story

This is disgusting. There are no valid clinical grounds to deny a patient surgery to repair a severely broken bone on the basis of his being a smoker. All this amounts to is the surgeons and health trust punishing this poor man for failing to follow their advice. But you don't punish someone by denying them a necessary surgery. If we punished all patients who fail to heed their doctor's advice in this way, we would perform almost no surgeries.

While I'm not familiar with clinical treatment in Great Britain, I am quite familiar with surgery for broken bones in the United States, and I have never seen a patient refused surgery to repair a severely broken bone because he or she smokes. In fact, to delay the surgery for that reason would likely put the surgeon at risk for a malpractice suit, because the longer you wait to repair the broken bones, the more damage that is done and the more difficult it becomes to do the repair successfully.

In my view, this represents medical malpractice. How the surgeons could possibly argue that they are acting in the best clinical interests of this patient is beyond me. The very fact that they are making such a judgment for the patient is extremely scary. Physicians are supposed to be in the business of treating injuries, not lecturing their patients about unrelated health behaviors and then punishing those patients by denying them the clinically indicated repair.

(Thanks to GreatScot for the tip.)

More Science by Press Release on Smoking Bans and Heart Attacks; Mississippi Study Conclusions are Based on Shoddy Science with No Comparison Group

2009-11-10T11:28:00.006-05:00

Failure to Analyze Pre-Existing Trends in Heart Attacks Negates Conclusions of Study

A press release issued yesterday by Mississippi State University claims that a new study has demonstrated that a local smoking ban in Starkville resulted in a 27% decline in heart attacks.

According to the press release: "A Mississippi State study released Monday [Nov. 9] shows a 27 percent decrease in heart attacks among Starkville residents since the city passed a smoking ban in 2006. Researchers associated with the university report also are recommending a statewide public ban on smoking. The study by Robert McMillen and Dr. Robert Collins shows fewer heart attacks being treated at the Oktibbeha County Hospital. It focused on Starkville residents in the three-year span after the ban became law, compared to three years prior."

The Starkville smoking ban went into effect in May 2006. The researchers found that the rate of heart attack admissions among Starkville residents at the Oktibbeha County Hospital decreased by 27% from the three -year period proceeding the ban (2003 through 2005) to the three-year period following the ban (2006 through 2008). They attribute this decline to the smoking ban.

The study contains no comparison group, nor was there any assessment of baseline trends in heart attacks prior to the ban to determine whether the observed decline was occurring anyway, even without the smoking ban. Nevertheless, the study boldly concludes that this research "clearly demonstrates" that the smoking ban was what caused the 27% decline in heart attacks in Starkville.

The study was apparently not peer reviewed nor published, nor does it appear to be available to the public for scrutiny. Nevertheless, the conclusions have been widely disseminated through the media (example 1; example 2; example 3; example 4). Headlines boasted that: "Study Links Decline in Heart Attacks to Smoking Bans."

A summary of the study appears on the internet, but the actual study itself does not (at least I could not find it). According to the study summary: "The scientists compared the standardized number of heart attacks for three years prior to the smoke-free law and the three years following the enactment of the smoke-free law, and found that the number of heart attacks decreased substantially. Although these results are preliminary and the study will not be completed until several other Mississippi communities are examined, this finding highlights the immediate impact on health that smoke-free laws in Mississippi can have."

One of the study authors is quoted in the Starkville Daily News as quantifying the precise effect of the smoking ban on reduced heart attacks: "We have saved $750,000." This calculation assumes that all of the 27% decline in heart attacks during the period 2006-2008 was attributable to the smoking ban.

The Rest of the Story

The problem with the study, and the reason why I call it shoddy science, is that it fails to investigate whether or not the observed decline in heart attacks in Starkville was attributable to the smoking ban, or whether the decline was part of an already existing pattern of secular decline in heart attacks occurring throughout Mississippi that was happening anyway, and would have continued even in the absence of the smoking ban.

Just because you observe a decline in a particular phenomenon from before to after a given year does not mean that something which happened during that year is responsible for that decline. For example, there was an 11.3% decline in divorces in Mississippi from 2003 to 2008. Can I conclude that it was the Rebels upset victory over the Florida Gators in 2003 that led to this substantial decline in divorces?

Of course not. What is first necessary is to examine whether the observed decline differs from what was happening anyway. In other words, you have to go back in time and determine the baseline or pre-existing trends in the number of divorces. In Mississippi, from 2000 to 2003, the number of divorces declined by 6.0%. If you plot the number of divorces out over a long period of time, say from 2000 through 2008, you'll see that there has been a relatively steady decline over the entire study period, and there is no reason to believe that any particular event in 2003 had any effect on this trend.

Now, back to the study. The study compared the change in heart attacks in Starkville from 2003-2005 to 2006-2008 and found a 27% decline. What we need to know is: what was the decline in heart attacks during the previous period? In other words, what was the decline in heart attacks in Starkville from 2000-2002 to 2003-2005? Without that information, we cannot possibly determine whether the 27% decline was due to the smoking ban, or whether it was merely a reflection of a long-term, secular decline in heart attacks that was occurring anyway.

Importantly, the study cannot answer this question, at least with the data it currently analyzes. However, we can investigate this question by examining data on heart attack deaths for the state of Mississippi, which are available from the state Department of Health. Heart attack deaths are likely correlated highly with the number of heart attack admissions. So looking at the pre-existing trend in heart attack deaths in Mississippi gives us some indication of what would likely have been observed in Starkville in the absence of the smoking ban.

As it turns out, from 2000-2002 to 2003-2005, there was a 19.3% decline in heart attack deaths in Mississippi. And from the period 2000-2002 to 2006-2008, there was a 29.2% decline in heart attack deaths in Mississippi.

From 2003 to 2008, heart attack deaths in Mississippi fell by 19.1%. From 2002 to 2008, they fell by 29.4%. And from 2000 to 2008, they fell by more than one-third: by 33.9%.

This demonstrates that heart attacks were declining substantially in the state of Mississippi anyway, even in the absence of a smoking ban. It suggests that if Starkville had not enacted a smoking ban, the study still would have found a very large decline in heart attacks from 2003-2005 to 2006-2008.

Just looking at the change in heart attack deaths in the state from 2005 to 2006 (the first year of the Starkville smoking ban) alone, there was a large 8.7% decline. And for the entire period 2000-2006, there was a 29.7% decline. Thus, a decline in heart attacks in Starkville on the order of about 27% appears to be exactly what one would have expected in the absence of a smoking ban.

Given these facts, I do not understand how the study can conclude that the smoking ban in Starkville resulted in a 27% decline in heart attacks. I won't quibble and argue that the smoking ban had zero impact, but it certainly appears that a decline on the order of about 27% would have occurred anyway. I simply don't see how the study can attribute all 27% of the observed decline to the smoking ban.

The decline in heart attack deaths in Mississippi during the study period is a reflection of broader underlying trends in cardiovascular disease in the state. For example, cerebrovascular disease deaths in Mississippi declined by 21.3% from 2000 to 2008. From 2000-2002 to 2006-2008, there was a 20% reduction in cerebrovascular disease deaths in the state.

It's interesting that the study summary acknowledges that the study conclusions are preliminary and that the study will not be complete until other communities are examined (which is a good idea, because it will show that heart attacks have been declining throughout the state during the study period), but that the investigators nevertheless have no problem disseminating their unequivocal conclusions throughout the country through the media.

This is once again an example of science by press release. Although I have demonstrated that the study conclusion is flawed because at least a large part of the observed decline in heart attacks was attributable to the pre-existing secular trend of declining heart attacks in Mississippi, it is too late. The conclusions have already been disseminated, and I don't believe that these media outlets are now going to publish a retraction or a new article that says: "Remember that article last week about how the smoking ban in Starkville reduced heart attacks by 27% and saved $750,000. Well, never mind."

American Cancer Society Lying to Public While Playing Politics; Does the Truth No Longer Matter?

2009-11-09T07:39:00.000-05:00

On its web site, the American Cancer Society (ACS) states that it is supporting a ban on flavored cigarettes, which it asserts have long been used by tobacco companies to lure kids into smoking.

According to the ACS: "Candy, fruit and liquor-flavored cigarettes are smoked by school children in much higher numbers than adults. Cigarette makers have long seen sweetened cigarettes as a lure for catching young customers. The American Cancer Society supports a ban on these dangerous products."

The ACS also states: "A bill to eliminate flavored cigarettes passed the [New York] State Assembly in early 2009 and awaits action. We are hopeful this bill can become law this year."

The Rest of the Story

The bill passed by the New York State Assembly does not ban flavored cigarettes. It does not, for example, ban menthol-flavored cigarettes. It does not ban clove cigarettes. What it bans are a number of types of cigarettes that were already taken off the market several years ago. There is not a single brand of flavored cigarettes produced by Big Tobacco which is covered by this legislation. But what the bill does is specifically allow the most common flavored cigarettes - menthol and clove cigarettes - to remain on the market.

Thus, it is not true that the ACS is supporting a bill that would ban flavored cigarettes. It wouldn't ban flavored cigarettes. It would continue to allow menthol cigarettes. And it would continue to allow clove cigarettes. Thus, the supposed "ban" on flavored cigarettes turns out not to be a ban at all.

It's like stating that you support a ban on flavored toothpaste but that you are actually supporting a bill that exempts mint flavors and bubble gum. That's hardly a ban on flavored toothpaste.

It is also not true that the tobacco companies have long used the flavors banned by this legislation to lure kids to start smoking. There was one episode in which R.J. Reynolds introduced a few candy-flavored cigarette varieties but these were removed from the market. Other than that, the only flavor that has long been used by tobacco companies to lure kids to smoking is menthol. An that's not covered by the ban. So the American Cancer Society is full of crap when they assert that the cigarette flavors they seek to ban have long been used to lure children to start smoking.

It is also untrue that flavored cigarettes are currently smoked by youths in much higher numbers than among adults. If you don't count menthol, the overwhelming majority of youths are smoking non-flavored cigarettes, specifically: Marlboros, Camels, and Newports.

Finally, it is not true that the ACS is supporting a ban on these "dangerous," "flavored" tobacco products. The ACS is not supporting a ban on menthol-flavored cigarettes, the one type of flavored cigarette which is actually smoked by hundreds of thousands of youths. The ACS is supporting a ban on exactly zero products that are produced by Philip Morris, R.J. Reynolds, or Lorillard.

I challenge the ACS to name a single brand of cigarettes produced by Big Tobacco and smoked by any substantial proportion of youths that will be taken off the market as a result of the legislation it is supporting (even setting aside the fact that federal legislation has already removed these products from the market).

In contrast, I can list a host of flavored cigarette brands produced by Big Tobacco which are smoked by a huge proportion of youths and which will not be removed from the market by this legislation.

The issue here is not whether flavored cigarettes should or should not be removed from the market. The issue is why it is necessary for anti-smoking groups like the American Cancer Society to lie to the public and imply that legislation will remove flavored cigarettes when that legislation will do nothing of the sort.

Why is it necessary for groups like the American Cancer Society to deceive the public into thinking that they are doing something to protect our nation's youths when they are actually supporting a bill that fails to affect even a single Big Tobacco product? Why is it necessary for these groups to make false claims to the public in support of these policies?

How ironic it is that these anti-smoking groups are calling on the need for legislation specifically because they claim the tobacco companies have lied to, and are deceiving the American public, but that these groups are themselves lying to the public to support their meaningless policies?

NYC Council Bans "All" Flavored Tobacco Products; Well... Not Exactly... Exempt are the Products Which are Actually Used by Thousands of New Yorkers

2009-11-06T08:11:00.005-05:00

In a move described as intended to protect youths from the enticement to use tobacco products due to their flavorings, the New York City Council has enacted an ordinance which bans the sale of flavored tobacco products in the City.

According to an article in the Staten Island Advance: "The City Council voted overwhelmingly today to ban sales of all flavored tobacco products."

Well .... not exactly.

The ordinance exempts menthol cigarettes. It also exempts mint- and wintergreen-flavored or clove cigarettes.

According to an article in the New York Daily News: "Michele Bonan, regional director of advocacy for the American Cancer Society, one of the groups pushing the ban, said flavored tobacco is "Big Tobacco's version of training wheels" to attract young smokers."

The Council Speaker was quoted in the same article as stating that the ban was needed "to protect the children of New York City."

The Rest of the Story

This is an example of political cowardice, institutional racism, public deception, and what I would call sleazy politicking.

Political cowardice

This law represents political cowardice because these health groups and policy makers do not have the courage to actually promote or enact a policy that would actually accomplish what they state is the intended purpose. If the intent is to protect kids, then protect kids. Don't say that you're protecting kids from flavored cigarettes but then exempt the single most popular cigarette flavor among kids.

The products which are being affected by this ban are almost entirely products that are used by adults. Chocolate, watermelon, lemon, cherry, strawberry, and banana-flavored cigarettes are not popular among kids. In fact, not a single such product produced by Big Tobacco is even on the market. But the leading brands of cigarettes that are smoked by African American kids in New York City are all flavored cigarettes - flavored with menthol, which is exempt from the ban.

Institutional Racism

Given the large African American population in New York City, this bill actually reeks of institutional racism. How can you get up in front of the African American population in New York and tell them that we have just taken an action to protect the kids of New York City, but fail to take any action on the one cigarette flavoring that is most responsible for the addiction of African American children in the City. Are you saying that we are going to protect white kids from tobacco addiction, but we're not interested in protecting black kids?

Public Deception

By suggesting that non-menthol, flavored cigars are Big Tobacco's training wheels to attract smokers, the American Cancer Society is making a statement that is unsupported by any evidence. The true "training wheels" to attract smokers are products that go by the names of Marlboro, Camel, and Newport. These brands account for a solid 85 to 90 percent of the "training wheels" that Big Tobacco uses successfully to recruit new smokers.

The overwhelming majority of youth smokers begin to smoke not by trying cigars or cigarillos and then eventually switching to cigarettes, but by trying something known as a cigarette. The American Cancer Society is completely off base in suggesting that it is the banned flavored tobacco products that have anything to do with the youth smoking problem. In fact, it is the exempt products that are the ones addicting youths. The American Cancer Society is completely off base and I think it owes an apology to its constituents and the public.

Sleazy Politicking

This is an example of sleazy politicking because it represents an attempt by politicians to make it look like they are doing something to address the problem of youth smoking when in fact they are doing absolutely nothing of the sort. The so-called ban on tobacco flavorings is going to have no effect whatsoever on youth smoking because practically no youths use the brands that are being taken off the market due to this policy.

The policy is pure window-dressing. It allows politicians as well as health groups in New York City to make it look like they are accomplishing something to protect children without actually having to do anything. And they are specifically avoiding the difficult move which would actually make a difference: getting rid of the menthol cigarettes which are addicting more than 75% of African American youth smokers in the City.

American Academy of Pediatrics Calls for Ban on Electronic Cigarettes, But Fails to Disclose Its Huge Conflict of Interest with Big Pharma

2009-11-05T08:52:00.003-05:00

In a previous post, I pointed out that every national anti-smoking organization which has called for the prohibition of electronic cigarettes has been found to have financial ties to Big Pharma. I thought this pattern had been broken when I saw a press release from the American Academy of Pediatrics calling for electronic cigarettes to be banned. I assumed that if the Academy had a financial conflict of interest with pharmaceutical companies, it would disclose it in the press release, as would be ethical behavior for a public health organization. Thus, I assumed that the pattern had been broken. What I didn't know was the rest of the story.

The Story

On October 20, the American Academy of Pediatrics issued a press release calling for a ban on electronic cigarettes.

According to the press release: "The AAP's work to eliminate children's exposure to tobacco and secondhand smoke is spearheaded at the AAP Julius B. Richmond Center, which was established in 2006. The AAP recommends bans on tobacco advertising in all media, and restrictions on the depiction of tobacco in movies and television. In addition to laws banning the sale of tobacco products to children, the AAP calls for bans on candy cigarettes, cigars, and other products that imitate smoking or tobacco use. E-cigarettes (electronic cigarettes) should also be banned. The sale of tobacco products on the same premises as pharmacies should be eliminated, including pharmacies located in supermarkets."

The Rest of the Story

It turns out that the American Academy of Pediatrics has a massive conflict of interest by virtue of substantial financial sponsorships by Big Pharma. A large number of pharmaceutical companies are major sponsors of the Academy's upcoming 2009 annual conference.

According to the conference web site, pharmaceutical company sponsors of the conference at the "gold" level include:

GlaxoSmithKline
Johnson & Johnson
McNeil Pediatrics
Merck
Wyeth
Pfizer
Sciele

Many of these pharmaceutical companies produce nicotine replacement products or other smoking cessation drugs for which electronic cigarettes pose a huge threat. While FDA-approved smoking cessation medications are highly ineffective, with long-term success rates of only about 8-10%, electronic cigarettes appear to be much more effective, probably because they simulate the act of smoking, thus addressing both the behavioral and pharmacologic aspects of the smoking addiction.

To make a national recommendation that electronic cigarettes be banned without disclosing its severe financial conflict of interest with Big Pharma is, in my view, unethical. The financial conflict of interest could be perceived as influencing the Academy's policy on electronic cigarettes, since a ban on these apparently very effective smoking cessation devices is a move that protects pharmaceutical company profits from what would otherwise be a severe threat to their business.

Unfortunately, a ban on electronic cigarettes would also be a public health tragedy, as it would force hundreds of thousands of ex-smokers to return to cigarette smoking, and it would therefore do massive harm - causing disease and death among people who otherwise would have continued to regain their health.

It is a shame that while the American Academy of Pediatrics cares about children, it does not seem to care about those kids' parents, many of whom are going to become very ill or die if the Academy's policy recommendation on electronic cigarettes is heeded.

But regardless of the inappropriateness of the policy recommendation itself, the rest of the story is that the American Academy of Pediatrics has violated basic ethical principles of conduct by making a national policy recommendation on electronic cigarettes without disclosing its massive financial conflict of interest with a host of pharmaceutical companies whose products are being severely threatened by the increasingly popularity of electronic cigarettes.

Santa Cruz Bans Smoking on Downtown Streets and All City Parking Lots

2009-11-03T08:09:00.001-05:00

According to an article on the web site of San Francisco's CBS television affiliate, the Santa Cruz City Council has enacted an ordinance that bans smoking in all city parks, in parking lots and on streets surrounding all city buildings, and on a number of downtown streets, including Pacific Avenue as well as Beach Street between the Municipal Wharf and Third Street.

According to the chair of the Santa Cruz County Tobacco Education Coalition, this law is necessary because: "There is no safe level of exposure to secondhand smoke indoors or outdoors."

The Rest of the Story

Well, if there is no safe level of exposure to secondhand smoke outdoors, then why only ban smoking on Pacific Avenue and on Beach Street between the Municipal Wharf and Third Street? Why not ban smoking on all streets, sidewalks, and parking lots in Santa Cruz? How can the City Council possibly justify allowing people to be exposed to secondhand smoke throughout the rest of the city if there is no safe level of exposure to this smoke? And how could the Santa Cruz County Tobacco Education Coalition possibly support an ordinance which fails to protect people on the majority of the streets, sidewalks, and parking lots in Santa Cruz?

Moreover, how can the Santa Cruz City Council justify allowing people to be exposed to diesel exhaust in the city? There is no safe level of exposure to diesel exhaust, either inside or outside. Diesel exhaust contains known carcinogens and also causes heart and lung disease. Since there is no safe level of exposure to any carcinogen, there is no safe level of exposure to diesel exhaust in Santa Cruz.

There is also no safe level of exposure to radon, a proven carcinogen. Is the Santa Cruz City Council doing radon testing on all homes in the city and condemning those homes found to contain detectable levels of radon?

There is no safe level of exposure to arsenic, another carcinogen. However, the Santa Cruz city water supply was found to have levels of arsenic of up to 2.5 ppb in 2008. And tetrachloroethylene, another carcinogen, was also detected in the Santa Cruz drinking water supply in 2008. The treated drinking water in Santa Cruz was reported to have trihalomethane levels of up to 87 ppb in 2008. Many of these compounds are considered carcinogenic, and there is therefore no safe level of exposure.

Is the Santa Cruz City Council notifying its residents that there is no safe level of exposure to the city's water supply?

You see, this is the problem: when the only justification for banning an exposure is that you believe no person should ever have to be exposed to any level of that substance, then you open yourself up for this kind of criticism. This is why it is important to be able to justify smoking bans based on actual evidence of substantial exposure and significant health effects. But if all you can fall back on is that there is no safe level of exposure to secondhand smoke outdoors - even a whiff of it - then you are no longer acting in a consistent and justified manner.

Perhaps Santa Cruz should send its residents a warning noting that there is no safe level of exposure to drinking water in the city. Then they could use diesel trucks to bring in bottled water to any and all.

Published Study Shows No Effect of New Zealand Smoking Ban on Acute Cardiac Events During First Year; Study Not Considered by IOM Committee Report

2009-11-02T06:02:00.001-05:00

A peer-reviewed study published in the journal Tobacco Control reports no effect of New Zealand's smoking ban on admissions for acute cardiac events during the first year the law was in force (see: Edwards R, et al. After the smoke has cleared: evaluation of the impact of a new national smoke-free law in New Zealand. Tobacco Control 2008; 17:e2).

On December 10, 2004, New Zealand's existing smoke-free workplace law was amended to include all restaurants, bars, casinos, and clubs. The law resulted in significant declines in secondhand smoke exposure during the first year of implementation, and it affected a large population of 4.3 million people. There is a stable, national data collection system that covers all hospitals. All of these factors make this study population an ideal one to examine the relationship between the implementation of the smoking ban and acute changes in hospital admissions for acute cardiac events.

The study examined national data on hospitalizations for heart attacks and unstable angina from the New Zealand Health Information Service for the seven years prior to the smoking ban and one year following the ban. Poisson regression analysis was used to model the trends in hospitalization rates and to determine the significance of observed changes in hospitalization rates following implementation of the smoking ban.

In the year following the smoking ban, the rate of hospitalization for acute myocardial infarctions (heart attacks) increased in New Zealand. There was no significant difference in the pre- and post-ban trends.

Unstable angina admissions decreased in the year after the smoking ban, but there was no significant difference in the pre- and post-ban trends in the Poisson regression analysis.

When combining heart attacks and unstable angina to look at trends in the rate for all acute coronary events (also known as acute coronary syndrome), there was no significant change in acute coronary events from before to after the smoking ban, and no significant difference in the pre- and post-ban trends in the Poisson regression analysis.

The paper concludes: "There was therefore no clear evidence that the hospitalisation rate for these health outcomes reduced in the first 12 months after implementation of the SEAA [Smoke-free Environments Amendment Act]."

The Rest of the Story

While this is a published study that fails to find any significant effect of a national smoking ban in New Zealand on heart attack admissions, this paper was not considered - or even mentioned - in the Institute of Medicine (IOM) report that purported to review all published studies that examined the effect of smoking bans on heart attacks.

It would therefore be more accurate to say that the IOM committee reviewed all published studies which reported a significant effect of smoking bans on heart attacks, but excluded a critical published study that failed to support the report's conclusion.

The IOM committee has defended its failure to consider important data from Scotland, England, Wales, Iceland, several U.S. states, and the U.S. as a whole by arguing that such data are unpublished (even though these data are simply unbiased hospital figures). Here, however, the committee can no longer provide the same defense, since these data were published in a reputable peer-reviewed journal.

The population covered in this study is huge - 4.3 million people. Thus, it provides much more reliable information than the results from small communities like Helena (25,000), Pueblo (157,000), and Bowling Green (55,000).

The New Zealand results add evidence to my previous assertion that the only studies to have found large effects of smoking bans on heart attacks are in very small communities, and that these results are therefore most likely due to chance. Every time a large population has been studied, there has either been no effect or such a small effect that it cannot be differentiated from underlying secular trends in heart attacks, which have generally been declining, even in the absence of smoking bans.

The rest of the story is that we have here a published study which reports no short-term effect of a national smoking ban in New Zealand on heart attack rates. The study itself concludes that there is no evidence of any effect of the smoking ban on heart attack rates during the first year of implementation. Will the anti-smoking groups which have communicated to the public the results of positive studies now share the findings of this negative study?

I challenge the anti-smoking groups which reported the results of the Helena, Pueblo, Bowling Green, or other studies, and/or which reported the results of the IOM report to disclose to the public the results of this study, which fails to show any short-term effect of a national smoking ban on heart attacks.

I don't think any anti-smoking group will take this challenge, however. Why? Because I don't think that these groups really care about the scientific truth. I think they only care about sharing science when it is favorable to their cause and when it confirms their pre-determined conclusions.

In fact, I am so confident that no anti-smoking group will disseminate the results of the New Zealand study that I will back up my challenge by offering a $100 cash reward to the first anti-smoking group that shares the negative New Zealand results publicly on its web site.

I have been arguing for a long time that disseminating these premature conclusions - derived largely from shoddy science - is a huge mistake because eventually larger studies would come out which refuted these claims. Well now that is exactly what is starting to happen. But unfortunately, anti-smoking groups have tied the need for smoking bans to these data about dramatic, immediate effects on heart attacks. Now that this no longer appears to be the case, it hurts our arguments for smoke-free laws, because we've tied these laws to decreased heart attacks.

There are substantial, dramatic, short-term health effects from smoking bans, due not to the immediate reduction of heart attacks, but to the improvement of workers' respiratory health. There are marked improvements in these workers ability to breathe. That, in my view, is enough to support the smoking bans. But by tying them to the purported dramatic effects on heart attacks, we've now weakened our case substantially. What are we going to say now, that it doesn't matter whether smoking bans reduce heart attacks? I'm afraid it's too late for that. We've kind of put our foot in our mouths. That's what can happen when you let scientific integrity go by the wayside. Better to stick to solid science in the first place and refrain from drawing sweeping conclusions before there is enough evidence to support those conclusions.

Wisdom (or Lack Thereof) of FDA Tobacco Law Debated at Boston University School of Public Health's Bicknell Lectureship

2009-10-31T15:20:00.002-04:00

A summary of the Bicknell symposium is available on the School's web site. The actual video of the event will be made available soon.

As far as my opinions and similar sentiments by Patrick Basham (Democracy Institute) expressed during the panel discussion, the article summarizes them as follows:

"The other two panelists -- Patrick Basham, founding director of the Democracy Institute, and Michael Siegel, professor of community health sciences at BUSPH -- argued that handing tobacco regulation over to the FDA was a colossal mistake that would benefit cigarette manufacturer Philip Morris, rather than smokers. They noted that Philip Morris executives had a hand in crafting the bill, and they argued that provisions making it difficult for companies to introduce new, potentially safer smoking-related products into the marketplace would protect the company's market share." ...

"The uncomfortable reality we face this morning is that this legislation is simply bad news," Basham said. He said the FDA was not up to the task of finding ways to "make an unsafe product safer." He also said that the process of "validating new low-risk products is so cumbersome, it discourages new products... The FDA may deny smokers access to new products that may save their lives."

"Siegel was equally critical of the law, calling it "an absolutely absurd approach to the tobacco problem" that sets a "terrible precedent." "It puts the FDA into the business of approving deadly products. I think it really undermines the entire federal system of health regulation. They are approving products that are killing people," he said. Siegel argued that the legislation puts the FDA in the position of "deceiving consumers" by putting its stamp of approval on products that the agency may deem as "safer cigarettes" because they have reduced levels of carcinogens."

"There's no connection necessarily between levels of carcinogens and safety of the product," Siegel said, explaining that tobacco smoke contains more than 10,000 chemicals, only a fraction of which have been identified."

"Is there a safer cigarette?" he asked. "No, not in terms of what FDA can do -- tinkering with ingredients. We don’t know if those changes will result in a reduction in disease. We don’t have biomarkers for disease risk. We don’t have scientific knowledge to know if we have produced a safer cigarette. We don’t have that science."

"Siegel argued that the FDA's recent warnings about the possible dangers of e-cigarettes -- battery-powered devices that provide tobacco-less doses of nicotine in a vaporized solution -- were troubling, given that such devices are sure to be proven safer than actual cigarettes. Holding up an e-cigarette loaded with a glycerine cartridge, he said, "If we put in a nicotine cartridge, is it 'safe'? Probably not. But is it safer [than tobacco-containing cigarettes]? Yes."

"He said he worried that it would take years for the FDA to evaluate and approve e-cigarettes for sale, when they have been shown to be an effective quit-smoking product."

Zogby Poll Shows Public Support for Keeping Electronic Cigarettes Available as a Smoking Cessation Device

2009-10-31T15:06:00.002-04:00

According to a Zogby poll, 65% of those who have an opinion about whether electronic cigarettes should remain available to people trying to quit smoking believe that these products should remain on the market. While 28% of adults had no opinion or were not sure, 47% answered "yes" and only 25% answered "no" to the question: "Do you think electronic cigarettes should be an option available to people trying to quit smoking, similar to the patches, gum, and lozenges currently on the market?"

According to Zogby International: "A strong majority of Americans want to see electronic cigarettes regulated by the U.S. Food and Drug Administration (59%), but nearly half (47%) say the smokeless devices should be an option available to people trying to quit smoking, similar to patches, gum and lozenges currently on the market, and that number increases to 57% among those who have heard about ecigarettes prior to taking the poll. ... In the hunt for a safer cigarette, electronic cigarettes, often referred to as e-cigarettes, are becoming a popular option among those either trying to quit or who are looking to replace standard tobacco smokes with an alternative that manufacturers claim to be safer. Ecigarettes vaporize a solution often containing nicotine, but there is no smoke, just odorless water vapor, and produce almost no dangerous carcinogens."

The Rest of the Story

To me, the most important finding is that among those who have heard of electronic cigarettes, 57% believe they should remain on the market as an option for smokers who may wish to try to quit.

What is sad is that the overwhelming majority of anti-smoking groups do not want these devices to remain on the market to help smokers quit. Such a policy would result in perhaps hundreds of thousands of ex-smokers returning to cigarette smoking, which would have tragic consequences in terms of disease and death.

It's nice to see that the American public has more good sense than these anti-smoking groups.

New Study Finds Nicotine Gum May Pose Carcinogen Hazard to NRT Users; Will Anti-Smoking Groups Call for Removal of Oral NRT Products from Market?

2009-10-29T10:41:00.003-04:00

A new study published online ahead of print in the journal Cancer Research reports that the use of nicotine gum is associated with significant exposure to a potent carcinogen and concludes that oral nicotine replacement therapy (NRT) use therefore poses a potential carcinogenic hazard to some users. The same problem was not detected with the nicotine patch. Since the study concludes that the carcinogens were likely formed in the stomach, the problem would also not be expected to occur with the use of nicotine inhalers or electronic cigarettes.

In the study, urine levels of NNN - a potent carcinogen - were measured at baseline in smokers. Then, the smokers quit smoking by using either nicotine patches, nicotine gum, or nicotine lozenges. The group was followed for a period of two months after quitting smoking, with periodic follow-up measurements of NNN in their urine.

The major results and conclusion of the study was as follows:

"In 13 of 34 nicotine gum or lozenge users from both studies, total NNN at one or more time points after biochemically confirmed smoking cessation was comparable to, or considerably higher than, the baseline levels. For most of the subjects who used the nicotine patch as a smoking cessation aid, urinary total NNN at all post–quit time points was <37% of their mean baseline levels."

Of note, experts estimate that 36.6% of nicotine gum users are long-term users. Thus, these concerns are not just hypothetical ones.

Because the authors suggest that the NNN is being formed endogenously in the stomach in association with oral NRT use (this would explain the absence of this NNN problem in nicotine patch users), one would surmise that nicotine inhalers and electronic cigarettes do not pose similar problems of significant carcinogenic exposure to users due to the endogenous formation of NNN.

The Rest of the Story

Given this finding that oral NRT users may experience significant carcinogenic exposure and that this exposure could persist over long periods of time due to the way these products are commonly used, the question is: Why aren't the same anti-smoking groups which are calling for the removal of e-cigarettes from the market also calling for the removal of oral NRT products?

How can the Campaign for Tobacco-Free Kids, the American Heart Association, the American Lung Association, Action on Smoking and Health, and the American Legacy Foundation justify their calls for a ban on electronic cigarettes - which have not been shown to pose any carcinogenic hazard - while they remain silent about the risks of oral NRT use - which has now been shown to pose a significant carcinogenic hazard in a substantial proportion of users?

Clearly, there is a need for more research on these products, as suggested by the study authors. But why allow the product to remain on the market while these studies are conducted? If your attitude is that e-cigarettes must be taken off the market until further studies are conducted, then why should oral NRT products remain on the market during those same studies?

Let me make a clear distinction, however, between oral NRT products and electronic cigarettes. In the first case, there is clear evidence of a significant carcinogenic exposure that could potentially put users at risk, especially the 36.6% who use the product long-term. In the second case, there is not any evidence of a carcinogenic hazard, or any other hazard for that matter (other than the effects of nicotine itself, which is the same in all of these products).

For the anti-smoking groups that are calling for a ban on electronic cigarettes, I pose the following challenge: please identify one specific chemical exposure which is likely causing significant harmful effects in vapers.

For the anti-smoking groups that are calling for a ban on electronic cigarettes in public places, I pose a similar challenge: please identify one specific chemical exposure which is likely causing significant harmful effects in non-vapers.

It is all well and good to say: "We don't know if these products are safe. We should ban them until we know they are safe." But that's an uninformed opinion. There is plenty of scientific evidence out there already about the safety of the product. It has been studied extensively in the laboratory and its chemical components have been characterized. In fact, we know far more about the chemical components of electronic cigarettes than we do about the components of Marlboros.

Policy needs to be based on science, not pure conjecture. Let's look at the science. Based on the studies that have been done and the information about adverse effects of the product during its 3 years of use in the United States, as well as the characterization of the components in the product, what are the specific chemical exposures occurring among vapers and non-vapers that these anti-smoking groups posit may pose a significant health hazard?

If these groups cannot name a potential specific hazard, then it seems imprudent to ban the product, take it off the market, or even to ban its use in public, as this is going to result in forcing large numbers of vapers to go back to cigarette smoking.

You see, the anti-smoking groups have it all wrong. They are arguing that we need to ban the product because it is possible that it could be having an adverse effect on users (or non-users) and so to be safe and make sure that we are not causing harm, we need to carry out more studies (of course, they have not specified what studies are needed, since we already have 3 years of use of the product with no reported adverse effects).

Instead, I argue that to remove the product from the market, or even to ban its use in public, would result in a known and definite public health hazard: thousands of vapers returning to cigarette smoking, which is without doubt going to cause disease and death.

Public health is about reducing disease and death, not increasing it because of scientific uncertainty. Scientific uncertaintly is always going to be present to some degree. We cannot let that uncertainty get in the way of making rational decisions and we certainly cannot allow it to make us forget the information that we do have. And the information that we do have clearly suggests that pulling e-cigarettes off the market would do a lot more harm than good.

My analysis, of course, is subject to reconsideration. If any of the anti-smoking groups can present a specific chemical exposure that could likely be causing significant harm in vapers or non-vapers (other than the nicotine, which is of course present in all NRT products), then I will reconsider my position.

But based on the current evidence available, it is very clear to me that allowing ex-smokers to continue using electronic cigarettes, even in public places, is in the best interests of the public's health. Forcing them to return to cigarette smoking is the last thing in the world that public health groups should be doing.

Colleagues Accuse Me of Working for Big Tobacco and E-Cigarette Industry; Anti-Smoking Advocates Seem Unable to Address Opposing Views Substantively

2009-10-28T08:45:00.005-04:00

In response to my suggestion that electronic cigarettes could be helpful to smokers in quitting and my recent op-ed in the New York Daily News in which I strongly support workplace smoking bans but question the need to exaggerate the evidence and distort the science to achieve this goal, I have - in the past few days - been widely accused (publicly) by a number of my anti-smoking colleagues of working for Big Tobacco and for the electronic cigarette industry.

One colleague makes the false allegation that I work for the electronic cigarette industry, stating in a communication to another one of my close colleagues: "Perhaps in fairness you should let your readers know you are a spokesperson for the e-cigarette association."

Another colleague writes: "I have said this before and will repeat it every time you make these ignorant statements. I say ignorant because your "facts," perception and opinions are not based on truth. ... You are the enemy and I do not believe you should be allowed to continue on this listserve."

Some of you have already seen the first comment in response to my op-ed, which states: "Once again the New York Daily News allows a shill for the Tobacco Lobby to spew lies in its rag, what a joke, How much were they paid to allow this "commentary?"

This is just a sampling of the personal attacks and attempts at censorship I have received over the past few days.

The one thing I have not received - at all - is any substantive comments or arguments as to why my arguments are incorrect. In other words, no one has addressed my opposing views substantively. It has all been on the level of ad hominem attacks.

The Rest of the Story

These experiences are making me realize that the anti-smoking movement is very much a religious-like one and that it is based largely on ideology rather than science. Anti-smoking advocates are largely unable to respond substantively to opposing views from within; instead, they resort to personal attacks.

Moreover, there is an attempt to silence anyone with opposing views. As you can see, there is an effort afoot to try to get me banned from a secondhand smoke list-serve because I dare suggest that banning smoking everywhere outdoors may not be the most appropriate response to the problem and may not serve the goal of protecting nonsmokers from the hazards of tobacco smoke exposure.

In addition, not a single anti-smoking advocate has stepped forward publicly to defend me or my right to express my opinions (I have received numerous kind and supportive comments in private). There is clearly a group-think mentality that fosters the suppression of opposing views.

Why wouldn't there be? If someone with an opposing view is automatically considered to be and treated like "the enemy," then why would someone want to let their opposing views be known? This is an effective way of suppressing dissent and making sure that no one publicly strays from the established dogma (i.e., theology) of the movement.

At this point, I am not at all surprised at this response to my op-ed and my commentary about the potential role of e-cigarettes in promoting smoking cessation. The only thing that does surprise me is the nature of the comments I made which led to these attacks.

My op-ed is decidedly anti-smoking and in it, I strongly advocate for universal bans on smoking in the workplace. I also strongly state that chronic tobacco smoke exposure is a cause of heart disease and lung cancer and that acute exposure exacerbates asthma and angina in people with those conditions. These views would be considered strongly anti-smoking by any objective observer. But that isn't enough to be a part of the tobacco control movement. You have to accept the entire theology or you aren't a part of the religion. If you support bans on smoking in workplaces, restaurants, bars, casinos, bingo parlors, bowling alleys, billiard halls, stadiums, arenas, and other outdoor locations where nonsmokers are not easily able to avoid exposure, but you think it's going too far to ban smoking in all outdoors locations, such as huge, wide-open parks, then you are the "enemy" and you must be working for the tobacco industry. And you certainly shouldn't be allowed to express your opinion to others in the movement.

If you opine that electronic cigarettes might just be an effective way of helping many smokers stay off cigarettes (which appears to be unequivocally true based on the evidence), you could not possibly be expressing an objective opinion. You - by definition - must be working for the electronic cigarette industry. Or even if you aren't, you need to be attacked as working for the industry in order to discredit your opinion. After all, we wouldn't want to promote something that suggests that the "act" of smoking - even if it is far less harmful than actual smoking and will save lives - is in any way acceptable. It's clear that what we are fighting is not disease and death, it's the "act" and "idea" of going through "smoking-like" motions.

Ultimately, the reason why these anti-smoking advocates (i.e., colleagues) are unable to respond substantively and have to resort to ad hominem attacks is that they simply don't have scientific evidence to support their positions. They are left with nothing other than a personal attack. To address these issues substantively would be to admit defeat and to have to acknowledge that they were wrong. Better to go into attack mode and try to quell the dissenting opinion.

What is apparent is that my commentaries - exposing the truth - is having an impact. Nothing threatens anti-smoking groups and activists as much as the truth, when it doesn't support their statements or positions. And clearly, many of these advocates have no problem discarding the truth when making false accusations against their very own colleagues when they dare to state an opposing view.

Now the public knows the rest of the story. My hope is that the truth will ultimately prevail.

Americans for Nonsmokers' Rights Now Supporting Bans on Vaping in Public Places

2009-10-27T08:02:00.000-04:00

This weekend, Americans for Nonsmokers' Rights (ANR) apparently adopted a new position in which it is now advocating for bans on electronic cigarette use in public places. It adopted new model ordinance language which includes e-cigarettes in smoking bans and it is encouraging smoke-free advocates to use this language in future ordinances.

ANR writes to alert its constituents as follows: "We want to alert the field that the "Electronic Cigarette Association" (ECA) is lobbying against the Marion County/Indianapolis smokefree bill. The fast growing electronic cigarette industry is trying to be sure that its products will circumvent smokefree workplace and public place laws. The Indianapolis bill would strengthen the city's law to include bars and also add electronic cigarettes to the definition of smoking. Just to clarify, this isn't saying that people can't use these products, but rather - that electronic cigarettes should be treated like traditional cigarettes and should not be used indoors or in any way that may put others at risk. While the e-cigarette industry claims their products are "safe", the health risks are still unknown -- both to the smoker and those around them."

The Rest of the Story

ANR's decision to promote a ban on electronic cigarette use in public is troubling because it means that anti-smoking groups will now admittedly be lobbying for bans on a public behavior without any evidence that such behavior is harmful to the public. This represents a significant shift from ANR's support for workplace smoking bans, where there is evidence of harm to the public. With vaping, there is no existing evidence that the "secondhand vapor" poses any harm to non-users. Nor has any potentially harmful exposure been identified or even speculated. ANR readily admits that there is no evidence of any hazards from "secondhand vaping."

Thus, ANR is now promoting bans on public vaping without any evidence that vaping poses any hazard to the public.

In my view, this undermines the tobacco control movement's efforts to promote smoke-free policies because we can no longer argue that our policies are backed up by scientific evidence which shows that these policies are necessary to protect people from well-recognized hazards.

In addition, we now give opponents of smoke-free laws strong ammunition to use against us. They can rightly argue that we are simply trying to get rid of even the "act" of smoking in public, even when there is no demonstrable evidence of harm to nonsmokers.

I see it as a terrible precedent to start lobbying for laws when we are not actually sure that the law is necessary to protect the public from any hazard. If you are going to interfere with the autonomy of business owners, you ought to have a pretty strong reason to do so. In my mind, that means actual evidence that the exposure is a significant hazard. Mere speculation that there might be a hazard -- without any specific evidence to support that speculation -- is not sufficient, I believe, to justify these types of bans.

One anti-smoking group - Smokefree Pennsylvania - under the leadership of Bill Godshall, has been working to try to educate groups like ANR about the scientific facts. Unfortunately, Godshall's advice was not heeded and the result is the group's support for a policy that promotes a ban on vaping in public with no evidence of any harmful effect of such behavior.

As Godshall has argued, we in tobacco control should be trying to do everything we can to help smokers quit. Thus, we should be embracing electronic cigarettes rather than putting obstacles in the way of people using this product. The best way to reduce secondhand smoke exposure is to reduce cigarette smoking. Encouraging smokers to quit is the best thing we can do to reduce secondhand smoke, and the use of e-cigarettes to quit smoking seems to be a very effective and popular strategy.

The rest of the story is that through this new position, it appears that what we are opposing is not the imposition of health risks on innocent bystanders but instead, the "act" of a person going through smoking-like motions in public, even if that behavior has not been shown to affect bystanders.

Tobacco Industry Using Aggressive Street and Sidewalk Smoking Bans to Prevent Indoor Smoking Bans, Including Those in Bars and Restaurants

2009-10-27T07:32:00.000-04:00

An enlightening article by Dr. Simon Chapman in the current issue of Tobacco Control presents the surprising news that Japan Tobacco is supporting strict and aggressive street smoking bans (see: Chapman S. Japanese street smoking bans: a Japan Tobacco foil to prevent clean indoor air policy? Tobacco Control 2009; 18:419).

The Rest of the Story

At first blush, it might seem shocking that a tobacco company would support such draconian smoking bans. But on closer examination, it turns out that the tobacco industry's support for these measures in Japan is actually a foil as Chapman calls it - an attempt to re-frame the issue so that attention is diverted from efforts to ban smoking indoors: in workplaces, including bars and restaurants.

As the article explains: "Senior Japan Tobacco representatives have been enthusiastic supporters of the street smoking bans, while maintaining staunch opposition to indoor smoking bans. Dr Yumiko Mochizuki of Japan’s National Cancer Centre suggests that the industry’s intense support of the policy may suggest it sees street bans as an important foil to hold off indoor bans. Because of the smaller number of cumulative "smoking hours" available, the number of cigarettes forgone because of street smoking bans would be incomparably smaller than would be caused by indoor workplace bans, including those in bars and restaurants. By supporting street bans, Japan Tobacco would calculate that it could ride the popular wave of Japanese anti-litter sentiment, basking in civic-minded corporate social responsibility. In doing so, it helps contribute to the continuing framing of public smoking as an issue of manners and consideration, cleanliness and safety, while its role in chronic disease is sidelined. Mochizuki argues that the Japanese model may well be being promoted as the way to go elsewhere in the often crowded cities of Asia."

This story should give anti-tobacco advocates in the U.S. some pause. I have argued that the ever-increasingly aggressive attempts to ban smoking almost everywhere - including the wide-open outdoors - is going to harm our efforts to ban smoking in workplaces where people actually need the protection. For one thing, it diverts attention from chronic exposure to secondhand smoke and puts the sole focus on acute, even fleeting exposures. Second, it casts us as anti-smoking zealots who are trying to eliminate all public smoking. Third, it takes us away from a strong scientific base. Fourth, it risks losing our credibility by asking the public to accept increasingly hysterical claims.

When you see tobacco companies starting to support a policy, you had better seriously re-examine your support for those policies. If the tobacco industry truly felt that street smoking bans would enhance the overall goal of protecting people from secondhand smoke, it would certainly not support these measures. Perhaps the industry is banking on a backlash and/or on a diversion of attention.

My own prediction is that the movement's new obsession with trying to extend smoking bans to the outdoors, including parks, streets, and sidewalks is going to backfire by diverting attention away from the need for bans on smoking in the workplace and from the effort to extend protection to all workers in bars, restaurants, and casinos. That's where our attention should be -- not on trying to protect fleeting exposure from any whiff of smoke in a public park, street, or sidewalk.

Dr. Chapman's commentary helps to elucidate why my op-ed in the New York Daily News was so important. Exaggerated health claims and the support of draconian policies that are not based on scientific evidence are hurting, not helping the smoke-free cause.

Op-Ed in NY Daily News Exposes Misleading Scientific Claims of Anti-Smoking Groups; Now Health Groups, Not Just Big Tobacco, are Deceiving the Public

2009-10-26T11:00:00.000-04:00

An op-ed that appears in today's New York Daily News exposes the widespread misleading claims being made by anti-smoking groups about the acute cardiovascular effects of secondhand smoke. The unsupported and biased conclusions of the IOM report about smoking bans and heart attacks are only one example of the loss of scientific integrity of the tobacco control movement, and that loss of integrity is now being publicly exposed.

The op-ed points to hundreds of claims by anti-smoking groups that are scientifically inaccurate; most of them relate to claims that brief secondhand smoke exposure causes hardening of the arteries (atherosclerosis), heart disease, fatal arrhythmias, or clinically meaningful heart or artery damage that puts even a healthy person at risk of suffering a heart attack or stroke.

Sadly, these claims are headlined by the Surgeon General himself, who stated that: "Even brief exposure to secondhand smoke has immediate adverse effects on the cardiovascular system and increases risk for heart disease and lung cancer."

There is no evidence whatsoever that a brief exposure to secondhand smoke poses any lung cancer risk, nor is there any evidence that a brief exposure can cause heart disease. The Surgeon General should have ended his sentence after stating that brief tobacco smoke exposure has immediate adverse effects on the cardiovascular system. Trying to falsely extrapolate from those adverse physiologic effects to heart disease and lung cancer turned an important piece of health information into a dishonest communication (i.e., a lie).

Other major claims called out in the op-ed are Americans for Nonsmokers' Rights' (ANR) claim that: "Even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Heart damage? In just a half hour? Equal to that of habitual smokers? What secondhand smoke does is cause endothelial dysfunction in nonsmokers and that endothelial dysfunction is similar to that seen in chronic active smokers. But endothelial dysfunction is hardly "heart damage." It is certainly misleading of ANR to imply that the damage caused by a brief tobacco smoke exposure is similar to the heart damage suffered by chronic active smokers who actually experience destruction of heart muscle due to heart attacks brought on by tobacco smoke-induced atherosclerosis of the coronary arteries.

Another claim called out in the op-ed is that of the American Cancer Society: "Immediate effects of secondhand smoke include cardiovascular problems such as damage to cell walls in the circulatory system, thickening of the blood and arteries, and arteriosclerosis (hardening of the arteries) or heart disease, increasing the chance of heart attack or stroke."

While it is true that brief secondhand smoke exposure does cause temporary damage to cell walls in the circulatory system and does thicken the blood, it cannot possibly cause hardening of the arteries -- which is a process that takes many years to develop. You can't walk into a bar with clean arteries and come out 30 minutes later with atherosclerotic arteries. Even 4 pack a day smokers do not develop atherosclerosis overnight.

A further claim called out in the op-ed is that of the New York City health department: "Just 30 minutes of exposure to second-hand smoke produces some of the same physical reactions that would occur from long-term smoking, and increases the risk of heart disease in non-smokers."

There is no way that a person can develop heart disease in 30 minutes. It typically takes at least 20 to 30 years, even in a chronic, active smoker.

What is the point of all of this exaggeration, deception, and lying? According to the op-ed, it appears that anti-smoking groups are feeling the sensationalization of the scientific evidence is necessary to support the increasingly aggressive agenda of banning smoking just about everywhere, including in the wide-open outdoors (such as in all areas of every public park in New York City).

The op-ed concludes: "By wildly exaggerating the health risks of secondhand smoke exposure, the anti-smoking groups are risking their credibility. They are threatening to undermine the public’s trust in their pronouncements about the very real evidence demonstrating that tobacco smoke exposure is a severe health hazard. In fact, the hysteria may actually convince smokers that active smoking is no worse than brief exposure to secondhand smoke, which could well undermine their appreciation of the severity of the health consequences of smoking. The well-documented effects of chronic exposure to secondhand smoke — which include heart disease and lung cancer — combined with the acute effects of brief exposure on individuals with existing respiratory and cardiac disease are enough to justify efforts to ban smoking in all workplaces, as well as in public places where nonsmokers cannot easily avoid smoke exposure, such as stadiums and arenas. We do not need to exaggerate the health effects of secondhand smoke. The truth is more than enough."

The Rest of the Story

Although I know that I am going to face severe criticism from many of my colleagues for going public with this criticism of anti-smoking groups, I feel that it is important to expose the truth about the science, and that I need to do so beyond just the confines of this blog. This is why I have tried to maintain a consistent presence on op-ed pages of major newspapers.

The anti-smoking movement is not going to change from within. I tried that for about five to seven years before even starting this blog and it produced no results. No one was interested in listening and I was merely attacked as being some sort of heretic. That was when I decided to go public. That was the beginning of the "rest" of the story.

I feel that it is only by exposing the deception of anti-smoking groups publicly that they are going to be held accountable for their statements and actions.

And while colleagues may criticize me for what they perceive as hurting the movement, I feel that in the long-run, what is hurting the movement is the loss of scientific integrity and that by trying to reform the movement and save its credibility, I am actually doing something that is desperately needed to save the movement.

Perhaps more importantly, I think it is important for the overall reputation of public health as a whole. We need to be perceived as credible. We need to be beyond reproach in our scientific communications to the public.

Remember, the main thing that has always separated us from the tobacco industry is our honesty. If we eliminate that separation by following Big Tobacco's lead and turning into a movement that misleads and deceives the public, then we lose all credibility. That means we also lose the ability to make a difference in the lives of the public. We lose the ability to save lives and protect the public's health.

Data from Australia Show No Effect of Smoking Bans on Heart Attack Admissions

2009-10-26T07:47:00.000-04:00

National data from all hospital admissions in Australia show no apparent effect of smoking bans that were enacted in the various Australian states between 2005 and 2007. The data are easily available online and Christopher Snowdon over at Velvet Glove, Iron Fist has produced graphs of long-term trends in heart attack admissions in Australia before and after these smoking bans. He provides analyses of both the national trend in heart attack admissions and in the state-specific heart attack trends, showing with an arrow the point at which the smoking ban became active in each of the states.

There is no apparent effect of the smoking ban on heart attack admissions in any of the states. The most important pieces of data are those for New South Wales and Victoria, because they contain the largest populations. In both, there was no apparent effect of the smoking ban on heart attacks. If anything, there was an increase in heart attacks associated with the first nine months of implementation of the smoking bans in those states.

As Snowdon notes: "Note that the Helena hypothesis specifically claimed a drop in heart attacks of 40% within the first six months of the ban. Although Victoria and New South Wales introduced their bans towards the end of the time-frame, there was still nine months between July 2007 and March 2008 for a drop in heart attacks to occur. Instead, the rate rose from 51,667 to 55,676 between 2006/07 and 2007/08."

These results are in accordance with the observations of several tobacco researchers in Australia who have previously told me that they failed to see any significant effect of smoking bans there on heart attack trends.

The Rest of the Story

Today's story adds to the list of states and countries for which national or state-specific data show no effect of the smoking ban, bringing the total up to 10. The strength of these data is that the entire country or state is included (there is no sampling), there is little concern about heart attack cases that may have presented to out-of-town hospitals, and the populations involved are quite large, helping to protect against random fluctuations in the data which could present the false appearance of a large increase or decrease in heart attacks from one year to the next.

As Snowdon writes, reflecting a similar sentiment about the importance of these population-based, large studies of national or state-specific data: "It would, however, be nice to think that journalists might ask themselves whether data collected by professional tobacco control advocates from obscure towns really trumps genuine hospital admissions data collected by professional statisticians from entire nations."

The fact that the largest declines in heart attacks in the published studies occurred in the smallest of communities and that data for every state or country studied so far fails to confirm any significant short-term effect of smoking bans on heart attacks argues against the validity of the conclusion reached by the Institute of Medicine (IOM) committee, which failed to examine the readily available heart attack admissions data from any of these 10 states and/or countries.

It is quite clear that the IOM report failed to provide any review of these unpublished data. Nevertheless, the committee claimed that it had comprehensively reviewed the unpublished data: the press release states: "The IOM committee conducted a comprehensive review of published and unpublished data and testimony on the relationship between secondhand smoke and short-term and long-term heart problems."

In my opinion, the premature rush to judgment by anti-smoking researchers and groups on the issue of smoking bans and heart attacks undermines both the scientific integrity and the scientific credibility of the tobacco control movement.

While the conclusions of anti-smoking groups about the smoking ban and heart attack studies is receiving widespread publicity, so is the criticism of these groups' unsupported pronouncements. For example, an op-ed in Sunday's New York Post by Jacob Sullum -- a senior editor of Reason Magazine -- calls the IOM committee out for its sloppy and biased review of the data.

Sullum writes: "a closer look at the IOM report, which was commissioned by the US Centers for Disease Control and Prevention, suggests its conclusions are based on a desire to promote smoking bans rather than a dispassionate examination of the evidence. Thousands of jurisdictions around the world restrict smoking. Some of them are bound to see significant drops in heart attacks purely by chance, while others will see no real change or significant increases. Focusing on the first group proves nothing unless it is noticeably bigger than the other two groups. The largest study of this issue, which used nationwide data instead of looking at cherry-picked communities, concluded that smoking bans in America "are not associated with statistically significant short-term declines in mortality or hospital admissions for myocardial infarction." ... That study, published by the National Bureau of Economic Research in March, suggests that publication bias -- the tendency to report positive findings and ignore negative ones -- explains the "consistent" results highlighted by the IOM committee. But even though the panelists say they tried to compensate for publication bias by looking for relevant data that did not appear in medical journals, they ignored the NBER paper, along with analyses that found no declines in heart attacks following smoking bans in California, Florida, New York, Oregon, England, Wales and Scotland." ...

"when people stop smoking, their heart-attack risk declines gradually over several years, and it's hard to see why the risk would fall any faster for people exposed to secondhand smoke. Furthermore, estimates from the CDC and the American Heart Association indicate that smoking and secondhand smoke together account for about 25 percent of heart-disease deaths. So how could a smoking ban, even one that eliminated all smoking, cut heart attacks by 40 percent (or 47 percent, as another study claimed)? The IOM panelists dodge these issues by declining to estimate the size or the timing of the impact from smoking bans, citing the limitations of the studies and the wide variations between them. But "if you can't even estimate the magnitude of an effect," notes Michael Siegel, a Boston University public-health professor who was one of the report's reviewers, "you are hardly in a position to conclude that [it] exceeds random variation combined with the known secular decline in heart-attack rates." ... Siegel, who faults the IOM committee's "sensationalistic" approach, is a longtime backer of smoking bans who nevertheless tries to separate his political advocacy from his scientific analysis. It's too bad the authors of the IOM report, who immediately used it as an excuse to demand strict smoking regulations throughout the country, did not follow his example."

It pains me to see the scientific integrity of the tobacco control movement imploding like this. While I support the same goal of protecting the public from secondhand smoke exposure (though not the agenda of spreading smoking bans to the wide-open outdoors), I think the scientific credibility of public health groups is our most prized possession. To squander that in an attempt to promote even a valuable public health policy is foolish. But more importantly, misrepresenting the scientific evidence to the public is, I believe, unethical. It is inconsistent with the ethical code of conduct of public health.

IOM Report Criticized for Failing to Consider Relevant Data, Coming to Pre-Determined Conclusion

2009-10-22T09:08:00.002-04:00

Over at Reason Magazine's Hit & Run blog, Jacob Sullum has criticized the Institute of Medicine (IOM) report on smoking bans and heart attacks for failing to consider relevant data and for reaching a pre-determined conclusion. In a post which he wittily but aptly entitles "Myocardial Infractions," Sullum describes how the IOM report not only failed to consider unpublished data which did not support the report's conclusion, but also drew conclusions that were inconsistent with the assertions made in the report itself.

While I had previously criticized the report for failing to consider unpublished, but relevant and significant data from Scotland, England, and Wales, Sullum points out that there are additional data from California, New York, Florida, Oregon, and the United States as a whole that were not considered and which do not support the report's conclusion that smoking bans result in substantial, short-term declines in heart attacks.

Sullum writes: "a closer look at the IOM report, which was commissioned by the U.S. Centers for Disease Control and Prevention, suggests its conclusions are based on a desire to promote smoking bans rather than a dispassionate examination of the evidence. Thousands of jurisdictions around the world restrict smoking. Some of them are bound to see significant drops in heart attacks purely by chance, while others will see no real change or significant increases. Focusing on the first group proves nothing unless it is noticeably bigger than the other two groups. The largest study of this issue, which used nationwide data instead of looking at cherry-picked communities, concluded that smoking bans in the U.S. "are not associated with statistically significant short-term declines in mortality or hospital admissions for myocardial infarction." It also found that "large short-term increases in myocardial infarction incidence following a workplace ban are as common as the large decreases reported in the published literature." That study, published by the National Bureau of Economic Research (NBER) in March, suggests that publication bias—the tendency to report positive findings and ignore negative ones—explains the "consistent" results highlighted by the IOM committee. But even though the panelists say they tried to compensate for publication bias by looking for relevant data that did not appear in medical journals, they ignored the NBER paper, along with analyses that found no declines in heart attacks following smoking bans in California, Florida, New York, Oregon, England, Wales, Scotland, and Denmark."

Sullum also points out that although the report emphasized that few (only two) of the studies actually looked separately at heart attacks among smokers and nonsmokers, it nevertheless concludes that smoking bans specifically reduce heart attacks among nonsmokers by reducing acute secondhand smoke exposure. As Sullum writes: "If smoking bans reduce heart attacks, the effect could be due to declines in smoking, declines in secondhand smoke exposure, or both. The IOM report settles on that last explanation, quite a leap given that 'only two of the studies distinguished between reductions in heart attacks suffered by smokers versus nonsmokers.'"

Sullum concludes: "Siegel, who faults the IOM committee’s "sensationalistic" approach, is a longtime supporter of smoking bans who nevertheless tries to separate his political advocacy from his scientific analysis. It’s too bad the authors of the IOM report, who immediately used it as an excuse to demand strict smoking regulations throughout the country, did not follow his example."

The Rest of the Story

Occasionally, a review of data on an epidemiologic issue will miss one or two studies. But in the case of the IOM report on smoking bans and heart attacks, the report fails to consider relevant, objective, population-based data from the following, each of which fails to find any effect of smoking bans on heart attacks, in the short-term:

1. Scotland
2. England
3. Wales
4. Denmark
5. Florida
6. California
7. Oregon
8. New York
9. United States

The IOM committee states that it did not consider the data from these nine states or countries because they were unpublished. In an email, a committee member states: "The data from England, Scotland and Wales and their analyses referred to in your email are not found in the peer-reviewed literature and, therefore, were not reviewed in the committee’s report. It was beyond the scope of our study to seek out data available from all the municipalities, counties, states or countries that might be relevant to smoking bans and to conduct our own original studies."

In another email, a committee member acknowledges that he had not even seen the relevant data referred to above.

It seems clear that the committee did not consider these unpublished data in its report.

However, the press release states: "The IOM committee conducted a comprehensive review of published and unpublished data and testimony on the relationship between secondhand smoke and short-term and long-term heart problems."

If the report failed to consider the unpublished data and at least one of the committee members acknowledges not having even looked at that data, then why does the press release untruthfully state that the committee conducted a comprehensive review of unpublished data? How comprehensive a review is one in which the data are apparently not even examined? How comprehensive a review is it if the unpublished data are not even mentioned in the report?

The committee is of course free to restrict its analysis to published data, but you can't have it both ways. You can't restrict your analysis to published data and then lie to the the public and tell them that you comprehensively reviewed the unpublished data as well.

Why not just tell the truth and state that you examined only published data, not unpublished data? Why is it that tobacco control groups seem to have so much trouble these days simply telling the truth?

The rest of the story is that the IOM report failed to consider important, significant, and relevant unpublished data from nine different states or countries which do not support the conclusion of a significant short-term reduction in heart attacks from smoking bans. This has resulted in a severe bias in the report because of the presence of publication bias: clearly, only the positive studies are being published. This throws the report's conclusions into serious doubt.

But the other aspect to the rest of the story is that rather than simply acknowledge that they failed to examine unpublished data, the committee has essentially lied to the public by claiming that it conducted a comprehensive review of the unpublished data. Bias is one thing, but dishonesty is quite another.

Conclusion of IOM Report on Smoking Bans and Heart Attacks is Invalid on its Face: An Epidemiologic Analysis of the Report's Major Conclusion

2009-10-21T08:42:00.002-04:00

Last week, an Institute of Medicine (IOM) committee released a report whose major conclusion was that smoking bans have a significant short-term effect on heart attacks, reducing the incidence of acute coronary event admissions to hospitals due in part to reduced secondhand smoke exposure. The press release headline read: "Smoking bans reduce the risk of heart attacks associated with secondhand smoke."

Although the report's conclusions have received widespread publicity, a little-noticed but severe flaw in the basic epidemiology/biostatistics foundation of the report renders its conclusion invalid.

In this commentary, I attempt to explain the nature of this flaw and why it renders the report's conclusion invalid.

The Rest of the Story

The report was very clear in asserting that the committee could draw no conclusion about the magnitude of the effect of smoking bans in reducing heart attack admissions. In fact, the report made it clear that the committee had no confidence in even estimating the magnitude of this effect.

According to the report: "However, because of the weaknesses discussed above and the variability among the studies, the committee has little confidence in the magnitude of the effects and, therefore, thought it inappropriate to attempt to estimate an effect size from such disparate designs and measures."

In other words, what the committee is saying is they have no confidence in making any estimate of the size of an effect of smoking bans on heart attack rates.

In epidemiology/biostatistics, we call this the "point estimate." The point estimate is the estimate of the magnitude of a particular association or effect. In other words, what is the estimate of the percentage by which smoking bans reduce heart attacks? Is it 4%, 10%, 20%, 47%?

The report makes it clear that we have no idea and that the studies are plagued with weaknesses such that there is no confidence in even making an estimate of the effect of smoking bans on heart attacks.

Note that I am not drawing my own conclusion about the quality of the studies. I am merely repeating what the report itself concludes.

Now, despite failing to be able to even guess what the point estimate might be, the report nevertheless clearly concludes that smoking bans cause a significant decrease in heart attacks. What this means is that the committee is certain that the 95% confidence interval around the point estimate for the effect of smoking bans does not include zero.

Suppose that the point estimate was 20%. Can one conclude that the effect on heart attacks is significant? It depends on the variability of the point estimate, which we can indicate through a confidence interval. With 95% certainty, what range are we sure that the actual point estimate falls into?

Suppose that the 95% confidence interval goes from 15% to 25%. Then, while we're not exactly sure whether the true effect is 15%, 20%, or 25%, we are sure that the effect is no lower than 15%, and we certainly know that it is greater than 0%. In other words, we can conclude that there is a significant effect of smoking bans on heart attacks.

In contrast, suppose that the 95% confidence interval goes from -5% to 50%. While we think the best estimate of the effect is a reduction of 20%, it could be anywhere between an increase of 5% and a reduction of 50%. The confidence interval includes zero (0%), meaning that we cannot conclude that there is a significant effect of smoking bans on heart attacks, because it is possible that the true effect is zero.

I hope readers see that in order to conclude that there is a significant effect of smoking bans in reducing heart attacks, one would have to derive a confidence interval and that confidence interval could not include zero. Another way of saying this is that the "lower bound" of the confidence interval would have to be greater than zero.

In essence, what the IOM report is concluding is that we have no idea what the point estimate for the reduction of heart attacks by smoking bans is, but we are nevertheless sure that the lower bound of the confidence interval around that point estimate does not go down as far as zero.

But there's two problems here.

First, you can't estimate the confidence interval unless you make some guess about the variability around the point estimate of the purported effect. If you haven't estimated a confidence interval, then you can't possibly conclude that the confidence interval doesn't include zero.

Second, if you can't even take a guess at a point estimate, then even if you know the variability around that estimate, you can't figure out the lower bound of the confidence interval, because you don't know where to start counting down from.

In other words, if you are not able to make a point estimate, then you have no way of knowing what the lower bound of the confidence interval is.

Do you see that the IOM report's conclusion is based on a complete leap of faith? What the report is saying is that we have no idea what the lower bound of the confidence interval is; however, we are nevertheless certain that it does not extend down as far as zero.

This is equivalent to drawing a pre-determined conclusion. If you are not willing to actually see what the true confidence interval is before drawing a causal conclusion, then you might as well just draw your conclusion prior to doing the actual review. It is a leap of faith, because it is accepting something without empirical evidence.

The committee provides no evidence about what the lower bound of the confidence interval is and it makes no attempt to estimate either a point estimate or a lower bound of the confidence interval around that estimate. Nevertheless, despite the complete absence of any empirical evidence of what that lower bound is, they are quite certain that the lower bound is greater than zero.

Note that I am not, in this commentary, even getting into the issue of how the failure to consider unpublished, but highly reliable, meaningful, relevant, and population-representative data from Scotland, England, Wales, Denmark, and the United States as a whole would lead to a biased point estimate. I am just noting that even taking the report's conclusions as a given, its ultimate conclusion is not supported and appears to be a leap of faith rather than a serious attempt to use the evidence to derive a lower bound for the confidence interval of any possible effect.

Finally, I have to say that if one of my students handed in a paper which did an epidemiologic analysis of a potential causal relationship and concluded in the paper that it was impossible to even make a guess as to the point estimate of the purported effect, I would hope that the student would not conclude the paper by stating: "While we have no idea what the point estimate is or the variability around that point estimate, I conclude nevertheless that the confidence interval must not cross zero." I suspect I would give the student a failing grade on the paper.

Just to be clear, I would love to be able to take a leap of faith and conclude that all of my efforts over the past 24 years have resulted in policies that produced dramatic declines in heart attacks within one to two years. But as scientists, our role is not to take leaps of faith. It is to consider the empirical evidence and base our conclusions on that scientific evidence.

It is not the IOM committee's fault that the underlying studies are frought with severe weaknesses, that only a few of them employed comparison groups, and that the existing evidence is simply not sufficient to even guess as to the point estimate for a purported effect. But you aren't required to draw a causal conclusion from weak data. You could also come out and say: "The evidence is suggestive of an effect, but we simply don't have enough evidence to draw a definitive causal conclusion at this point. We just can't rule out the possibility that random variation in heart attacks, especially in small communities, and the existing secular trend of decreasing heart attacks due to substantial advances in medical treatment for heart disease during the time period of these studies are a plausible alternative explanation for the observed declines in heart attack rates in these studies."

Instead, it appears that the report felt it necessary to draw a definitive causal conclusion, even in the absence of what is essentially its own admission that there is insufficient evidence to draw such a conclusion.

IOM Proceedings Introduced Bias into Report: Only One Side of Smoking Ban Studies Was Presented in Committee's Public Meetings

2009-10-20T08:05:00.000-04:00

Today, I reveal that another element of bias in the Institute of Medicine's report on the effect of smoking bans and heart attacks occurred in the proceedings that the Committee undertook in reviewing the relevant data.

The Committee held a public meeting in which it heard presentations by experts in the field covering various topics. According to the report, the topic of smoking bans was only presented by one expert: Dr. Stan Glantz.

The Rest of the Story

Dr. Glantz has a very particular view of the smoking ban studies. I have no problem with the Committee choosing to ask him to present his side of the issue. However, to achieve balance and entertain alternative hypotheses, the Committee should also have invited someone to present the other side of the issue.

If you only hear one side of the issue, then of course you are going to get a biased picture of the data out there. This could easily result in bias in the Committee's analysis and report.

It doesn't appear to me that there was a serious effort to elicit both sides of this scientific question because the Committee was only presented with one side of the picture. How could that not result in a biased analysis?

I hate to use the term, but it appears that the deck was stacked. None of the experts asked to address and provide background materials to the Committee had taken the position that the scientific evidence is not sufficient to conclude that smoking bans result in dramatic, immediate reductions in heart attacks. Thus, it is perhaps not surprising that the Committee failed to consider the multitude of data that refutes its ultimate conclusion.

For example, had I been asked to address the Committee, they would have had in hand all the relevant data from England, Scotland, Denmark, and Wales which showed no effect of the smoking bans in those countries on admissions for acute coronary events. At least they would have had the data in hand and could have considered it as part of its review. These data could also have been provided by any number of other experts in the field. But if you only review data that support a conclusion, you're going to end up drawing that conclusion, regardless of its validity.

The rest of the story is that not only is the report of the IOM committee on smoking bans and heart attacks biased, but the process that led to this report appears to be significantly biased as well.

Data from Denmark Show No Apparent Effect of Smoking Ban on Heart Attacks

2009-10-18T20:47:00.003-04:00

Data from a government study of the effects of the smoking ban in Denmark show no apparent impact of that smoking ban on heart attack hospital admission rates.

The study analyzed rates of hospitalization for heart attacks in all hospitals in Denmark for a period of five years prior to the smoking ban (implemented in August 2007) and 18 months after implementation of the ban. A statistical model controlled for age, month, and secular trends in heart attack rates. No effect of the smoking ban was detected for either 35-64 year-old males, 35-64 year-old females, 65-84 year-old males, or 65-84 year-old females.

The trends in heart attacks among one of these four groups - men ages 35-64 -- is shown in Figure 6 of the report. As can be seen, there is a clear trend of decreasing heart attack rates over time. Seasonal variation in heart attacks is also clear. There is no apparent effect of the smoking ban on the trend in heart attacks. According to the report, the graphs for each of the other three demographic groups are similar, with no apparent effect of the smoking ban on heart attacks in any of the four study groups.

An advantage of this study is that Denmark has an excellent national registry of heart attack admissions. In addition, the report notes that there were few changes in treatment of heart disease in the country during the period surrounding the implementation of the smoking ban.

The Rest of the Story

This is now the fourth country for which data show no short-term effect of the smoking ban on admissions for acute coronary events. The others are England, Scotland, and Wales. None of these findings were included in the Institute of Medicine report which concluded that smoking bans cause an immediate and substantial decline in heart attacks.

An important observation is that the few studies which found large effects of the smoking bans were in very small communities. None of the studies that covered larger populations -- states or countries -- found large effects and many of these studies found no effect. This suggests that the findings from isolated communities - like Helena and Pueblo - are merely random phenomena. The fact that these results cannot be confirmed in any population-based study is concerning.

This pattern of findings also confirms that there is a severe publication bias present. We now have data from four countries showing no short-term effects of the smoking ban on acute cardiovascular events, yet none of these studies have been published. Researchers have a hard time getting excited about negative results and so they are much less likely to decide to publish such data. In contrast, when they find an effect, they are excited about publishing the findings. This is clearly what is going on with these smoking ban and heart attack studies.

(Thanks to Klaus K. for kindly providing the English translation of this report).