Friday, February 29, 2008

French Heart Attack Conclusions are Based on One Data Point; Stroke Admissions Increased After Smoke-Free Bar Law; Shoddy Science Exposed

It turns out that the truth about the report released last week which purported to show a 15% decline in heart attack and stroke admissions in France due to the bar and restaurant smoking ban is not good: the entire conclusion that the French bar/restaurant smoking ban led to a 15% decline in heart attacks and stroke admissions is based on a single data point - one month worth of data following the ban.

As I reported yesterday, a press release issued last week by the European Society of Cardiology stated that a new study had found a 15% decline in heart attack and stroke admissions attributable to the smoking ban in France, which was implemented in January 2007. These results were widely reported in the media (example 1; example 2; example 3; example 4; example 5; example 6; example 7; example 8).

Here's the rest of the story:

It turns out that the ban on smoking in bars, restaurants, cafes, hotels, and casinos in France went into effect just two months ago - in January 2008 (a workplace smoking ban that excluded these venues went into effect one year earlier). The reported decline in heart attacks and strokes in France was not a decline that was observed based on a year's worth of data; instead, it was based on a single data point: the heart attack and stroke admission rate in January 2008, the first month in which the smoke-free bar and restaurant legislation was in effect.

So the first thing we find out is that the press release was very deceptive. It suggested that there were observations over a full year to document a real decline in heart attack and stroke admission rates. We find out, however, that the entire conclusion - and all of the media publicity that followed the press release - is based on a single data point!

It also turns out, when one reads the entire report, which I was finally able to find yesterday, that stroke admissions were actually slightly higher in January 2008 than in January 2007. The report concluded that there was a 12% decline in stroke admissions associated with the bar/restaurant smoking ban only because it compared the January 2008 rate with the rate in January of 2005 and 2006, which was higher. But the rate had lowered in 2007 and the report fails to make the logical comparison of the stroke rate in January 2008 with the rate one year earlier, when the bar and restaurant smoking ban was not in effect.

Interestingly, in concluding that the heart attack and stroke rate dropped by 15% after the bar and restaurant smoking ban, the report compares January 2008 with January 2007. Had the report done the same comparison for the stroke rates alone, it would have found that there was essentially no difference. To me, this calls into question the objectivity of the report's conclusions.

The Rest of the Story

I would never draw a conclusion like this based on a single data point - one month of data. The report uses as a baseline 24 months worth of data prior to the smoking ban. Then, to determine the trend in admissions after the ban, it uses 1 (ONE) month of data. That is ridiculous. If the rate subsequently increases in another month or two, the entire conclusion will be wiped out. It is far too early to draw such a conclusion.

In other words, while I was yesterday criticizing the report for concluding that the observed 15% decline in heart attacks and strokes was attributable to the smoking ban, today it is not even clear that one can conclude that there was a true decline in heart attacks and strokes (by which I mean a decline that reflects a real change rather than just random variation).

If one looks at the graph of heart attack and stroke trends, one will see that between March and April of 2007, there was a "huge" decline in the heart attack and stroke rate, much greater than the decline observed from January 2007 to January 2008. Thus, wide variations in these data exist based purely on random variation.

The report is not concluding, for example, that the heart attack/stroke rate in April 2007 had declined due to the workplace smoking ban, even though it is much lower than it was in April 2006. But such a conclusion would follow from the same logic being used to conclude that there was a 15% decline associated with the bar and restaurant smoking ban. The report does not make the former conclusion because it is apparent, after watching the trend for another month (the rate went back up in May), that the decline in admissions in April 2007 was simply random variation.

When one looks at the entire year's worth of data for 2007 compared to 2006, it is quite clear that there was no significant change in the heart attack and stroke rate. In order to determine whether the rate in 2008 is significantly lower than in 2007, one clearly needs more than just one, or even a few, months of data.

Similarly, the stroke admission rate in January 2007 was much lower than in January 2006. But the report does not conclude that the workplace smoking ban caused the stroke rate to drop. Instead, it concludes that the bar/restaurant smoking ban caused the stroke rate to drop, even though the rate in January 2008 was actually slightly higher than in January 2007.

The bottom line is that the report's conclusions are not objective, nor are they based on enough data to make them scientifically supportable. There is no journal I know of which would publish a study with this conclusion based on these data. But even though this study, in its present form, will never sustain peer review nor make it to publication, its conclusion has already been widely disseminated throughout the world and will undoubtedly play a role in influencing public policy makers' decisions. The report will undoubtedly be hailed by anti-smoking groups as evidence that smoking bans result in an immediate (and I mean immediate) decline in heart attacks.

Now you can see why I am so leery of the idea of science by press release.

The most interesting aspect of this story is whether or not anti-smoking groups will tout this study or whether they will criticize it because of its unsupportable conclusions.

My guess: they will tout the study, because despite its non-scientifically supportable conclusions, it comes down on the "right" side.

Thursday, February 28, 2008

More Science, or Mythology, by Press Release: French Smoking Ban Cuts Heart Attacks by 15%

According to a new, unpublished and apparently unreleased study whose results were issued via press release, the smoking ban in France has resulted in a 15% decline in emergency room heart attack admissions in the first year since the ban was implemented in January 2007. The press release, which also appeared on other news services, reports that there was a "striking" 15% decline in heart attack admissions in France in 2007, which it attributes to the implementation of a smoking ban, which was reported to have reduced secondhand smoke levels in restaurants by more than 35%, but not to have affected active smoking rates. The story is also reported elsewhere (example 1; example 2; example 3; example 4; example 5; example 6; example 7).

A detailed search of all of the articles in which the story was reported, including the press release itself and the websites of the organization which released it (the European Society of Cardiology), failed to find any link to the actual study.

No other details about the study were released, including:
  • how far back the trends in heart attacks were examined;
  • what control population was used to determine whether the observed trends were different from trends in other countries;
  • what other variables related to heart attack incidence were controlled for in the analysis;
  • what type of analysis was performed;
  • how secular trends in heart attack incidence were controlled for; and
  • how the researchers could ensure that the observed changes were not due to other factors, such as the increased use of statin drugs and better management of patients with heart disease.
The Rest of the Story

This is really getting ridiculous, and out of control. The days of tobacco control science appear to be over. Now, it appears to be just a public relations game. This appears to be the strategy:

1. Where a smoking ban has gone into effect, conduct a quick, shoddy analysis of heart attack trends.
2. Since heart attack rates are declining almost universally, you are pretty much assured of finding a decline in heart attacks after the implementation of the smoking ban.
3. Release your finding and your conclusion immediately via press release.
4. Do not bother to wait until your results have been peer reviewed or published before announcing your conclusions to the public.
5. Do not make your methods and results readily available for public scrutiny.
6. If it is later discovered and pointed out that your conclusion was invalid because you failed to account for underlying secular trends in heart attacks or random variation in the underlying trend, or if later analyses fail to bear out your conclusions, it won't matter because the results have already been widely disseminated and have become part of the popular knowledge about the topic.

I would point out that based on my long experience in tobacco control, this was not previously the modus operandi. In the "old" days, we were very hesitant to release findings to the public before the study had been peer reviewed. We went to great lengths to hold off on releasing scientific conclusions to the public until a paper was published. In the rare instances where results were released prior to publication, we made sure to make the entire study available so that the validity of the conclusions could be judged. It was rare, if not unheard of, to release study results only by press release, with the study itself and its methods cloaked in a veil of secrecy.

Now, public relations by press release is what passes for science in tobacco control.

This is truly sad for me to watch because it represents the deterioration of the scientific integrity of the tobacco control movement. It's very difficult to realize that I am a part of this (even though I am distancing myself from these tactics) and to maintain any good conscience about it.

Let me emphasize that I am arguing here not only that this is shoddy science but that the tactics are unethical. I do not believe it is appropriate to conduct science by press release. In general, conclusions like these should not be released publicly until a study is peer reviewed and published. In circumstances where the results are so important that one cannot wait until publication, one is, I believe, under an ethical obligation to make the full study available for public review and scrutiny. Otherwise, one is doing a great disservice to the public.

The real danger of science by press release is that once a conclusion is disseminated, it cannot be retracted or changed if it is subsequently found to be untrue. In addition, it is an inappropriate tactic because it essentially means that an organization can release any conclusion it wants, without having to worry about that conclusion being subject to public scrutiny.

Can you imagine if the tobacco industry practiced this strategy? We would be attacking the companies relentlessly. They actually know better than to sink to such a level. But for some reason, tobacco control organizations can get away with it. Presumably, if your cause is a good one, I guess you no longer are subject to basic standards of scientific ethics and integrity.

In terms of the scientific conclusion itself, it is simply not plausible given the limited data presented. Since smoking rates reportedly did not decline, then the study is essentially concluding that a 35% reduction in secondhand smoke levels in restaurants resulted in a 15% decline in heart attack admissions within one year. That's scientifically implausible.

The fact that secondhand smoke levels declined by only about 35% in restaurants seems to suggest that the smoking ban was quite ineffective. Compliance has apparently been poor. Data from Boston, for example, indicates that there was greater than a 95% reduction in secondhand smoke exposure following the implementation of a bar smoking ban. So a 35% reduction is hardly something to write home about (or issue a press release about).

The scientific truth is that the observed decline in heart attacks in France almost certainly reflects a secular change in acute cardiac events that is not attributable to the smoking ban, but to other factors.

Instead of spending their time taking credit for a decline in heart attacks which has little to do with the smoking ban, I think public health officials in France would be better served to figure out why the smoking ban is not working as well as it should be, and spend some time trying to actually enforce the law, rather than bragging about it.

Monday, February 25, 2008

Michigan Legislators Ask State Universities Not to Hire Smokers

According to an article in the Lansing State Journal, two Michigan state Senators have urged the presidents of the University of Michigan, Wayne State University, and Michigan State University to save the state money by refusing to hire smokers.

According to the article: "Leaders of Michigan's three largest research universities appeared before the state Senate Finance Committee on Tuesday hoping to hold onto a proposed budget increase by Gov. Jennifer Granholm. But at least two senators had a favor of their own to ask: Help us get the state's health care costs under control. Sen. Thomas George, R-Kalamazoo, challenged the presidents of the University of Michigan, Wayne State University and Michigan State University to find ways to make Michigan's population healthier, going so far as to ask the presidents to refuse to hire smokers. "Where can universities help us make the population healthier? I'm not talking building new buildings. I'm talking about changing the behavior of the state's population," George said. The request came in the first of a series of meetings between the committee and the presidents of the state's public universities as the budget is set for the next year. ... Sen. Bill Hardiman, R-Kentwood, echoed George's challenge. "It's a huge asset for the state of Michigan," he said of the University Research Corridor universities, "and you could have a major impact" in controlling health care costs."

The Rest of the Story

For the Michigan state university system to adopt such blatant employment discrimination would be disgraceful. And for state legislators to suggest that employment discrimination be instituted in order to save the state health care costs is troublesome.

We need to be trying to eliminate discrimination, not to institutionalize it.

Why should a university specifically not hire the most qualified teachers, researchers, and other faculty members, administrators, and staff for positions at its schools? It makes no sense.

If the point is to save money, then the university could save a lot more money by simply refusing to hire fat people as well. The health care costs of obesity mirror those of smoking. So the university should cleanse itself not only of smoking professors, but of fat professors as well.

The next to go should be those with high-fat diets, high in cholesterol and trans-fats. They are heart attacks waiting to happen, and why should the university hire those individuals when they could just as easily hire thin, nonsmoking vegetarian professors with low cholesterol levels and high consumption of organic fruits and vegetables?

The universities could save a lot of money by doing a sort of health cleansing of its personnel. Simply refuse to hire anyone with any personal behaviors or characteristics that pose risks for illness or disease. The first thing every job applicant should be required to do at her job interview is to step on a scale. Even better, a body fat analyzer.

Then, they should provide a urine sample to be tested for cotinine. Those with any measurable cotinine should be refused employment. After all, even 30 minutes of secondhand smoke can cause an immediate heart attack. Why take the risk of having to pay health care costs associated with that? Just refuse to hire anyone who reports that he is ever around secondhand smoke.

A dietary questionnaire should follow. Then, the applicant should be asked about his or her physical activity and exercise regimen. Finally, an inquiry into the applicant's sexual behavior. If time permits, the university hiring personnel might actually ask a couple of questions about the applicant's qualifications for the job.

This kind of discrimination and bigotry has no place in education. Or anywhere else for that matter.

I still believe that if any U.S. anti-smoking group would speak out against this discrimination, the move to deny employment to smokers would lose steam. Unfortunately, I'm not aware of a single U.S. anti-smoking group that has done so. To actually support the rights of people who have chosen to smoke would be heretical.

Tobacco Reporter Article Highlights Internal Squabble in Tobacco Control About Validity of Secondhand Smoke Health Claims

An article in the February issue of Tobacco Reporter highlights the internal fight going on within the tobacco control movement about whether anti-smoking groups are accurately communicating the acute cardiovascular effects of secondhand smoke (access to the article is free but requires a brief registration).

On one side of the squabble is me, who has been arguing for some time now that anti-smoking groups are distorting the truth and misrepresenting the science by claiming that 30 minutes of secondhand smoke exposure causes hardening of the arteries, fatal or catastrophic arrhythmias, clogged arteries, or heart attacks and strokes in otherwise healthy individuals. On the other side are a number of prominent anti-smoking advocates/researchers who have argued either that these misleading statements were made in published scientific articles or reports (which is not true) or that the omission of important caveats was necessary in order to make the statements understandable to the lay public (which is troubling).

The article, written by John Luik and entitled "All in the Family: A Quarrel Erupts in the Anti-Tobacco Movement About Scientific Accuracy and Telling the Truth," provides numerous examples of misleading statements made by anti-smoking groups suggesting that 30 minutes of tobacco smoke exposure can have fatal or catastrophic consequences, even among those without pre-existing heart disease.

Luik writes: "The anti-tobacco movement, however, has not been satisfied with these claims about ETS [that chronic exposure causes disease] that have had at least some connection, however tenuous, to science. Instead, they have continually pressed to make the “truth” about the risks of ETS more dramatic, more attention getting and more frightening. While part of this is attributable to the movement’s generally low regard for science and accuracy about tobacco risks, it is also driven by the fact that exaggerating the dangers of ETS is the most consistently successful way to push for not only smoke-free public places but private spaces as well. Simple, uncompromising and above all frightening messages about the risks of ETS appear to move even the most skeptical, reluctant and considered of policy makers."

"Consider a couple of examples of this new line of “truth” about the risks of ETS. Several studies have argued that comprehensive public smoking bans have been followed by almost immediate, dramatic and unprecedented declines in heart attack admissions to hospital emergency rooms. Even more dramatically, many anti-tobacco groups have claimed that a single exposure of just 30 minutes to secondhand smoke can increase a nonsmoker’s risk of having a fatal heart attack to that of a regular smoker. As we don’t have space to look at both of these claims, I will concentrate on the 30-minute peril." ...

"If this were the end of the story we could simply put this untruth down to more of the anti-tobacco lobby’s usual tactics of misrepresenting science in order to scare citizens, politicians and regulators into supporting draconian tobacco control policies. But this story has a decidedly different twist, which owes much to the efforts of Michael Siegel and his tobacco policy blog, The Rest of the Story."

"Siegel, who is an anti-tobacco activist at the Boston University School of Public Health and the author of a flawed study on ETS exposure among restaurant employees (Siegel “Involuntary smoking in the restaurant workplace: a review of employee exposure and health effects” JAMA 1993), has used his blog to take aim repeatedly at a variety of activist claims that he considers to be scientifically inaccurate. And at the center of his focus has been the claim about a heart attack risk for nonsmokers after 30 minutes of ETS exposure."

"As he writes in his blog for Dec. 12, 2007: “It is not true that 30 minutes of secondhand smoke exposure causes ANY heart damage, much less damage that is similar to that sustained after many years of active smoking. It is also not true that the hearts of nonsmokers exposed to secondhand smoke for 30 minutes are impaired in their ability to get life-giving blood.”"

"Siegel’s criticisms of the antis’ claims about the risk of a heart attack from a 30-minute ETS exposure have recently attracted considerable attention with an article and editorial in the New Scientist in November criticizing the anti-tobacco movement’s willingness to distort the “facts in order to make their case” about ETS, and also an article in the Wall Street Journal’s “Informed Reader” section."

"In response to these criticisms, ASH’s executive director, John Banzhaf, asserted that the claim was taken from the CDC. But this is not true since the CDC references the Otsuka study, which does not make this claim. Stanton Glantz, an anti from the University of California in San Francisco, rationalizes the misrepresentation by saying that “when you take the science and put it in the public domain you can’t include all the caveats. The messages have to be simplified so people can understand them.”"

"This, of course, is part of the old health promotion line first championed by former Canadian health minister Marc Lalonde, who argued that the public was essentially too stupid to understand the science behind lifestyle issues like drinking, smoking and dieting, so the “truth” necessary to get them to change their ways had to be presented without any troubling uncertainties. What it really says is that lying about the science is fine as long as it is for a good cause like creating a world without smoking and smokers."

"As Siegel noted in reply to Glantz “Are you kidding me? ... Should we also tell the public that drinking three beers causes cirrhosis of the liver, liver cancer, hepatitis, and potentially, death? ... Should public health practitioners therefore be putting out messages in which we remove all the ‘caveats’ and state that drinking three beers puts you at the same risk of death as being a chronic, lifelong alcoholic?”"

The Rest of the Story

The argument that anti-smoking groups can't tell the truth because there is not enough room to provide the necessary caveats is problematic, because if we in tobacco control do not need to be held to high standards of scientific integrity, then how can we argue that the tobacco companies, which don't have a particular responsibility to provide accurate information to the public, must be required to provide all such caveats?

Take, for example, the tobacco industry's use of the term "light" to describe certain brands of cigarettes. If we accept the argument that caveats need to be omitted to simplify communications to the public, then there is really nothing wrong with the industry's use of this term. After all, it is true that light cigarettes produce a lower nicotine yield when measured by a particular machine method mandated by the federal government.

What makes the term "light" deceptive is, in fact, the lack of a caveat to explain that the machine-measured yield has no particular relationship with actual human yields produced by real smoking behavior.

If we excuse ourselves from disclosing the caveats in our public statements, how can we take the tobacco companies to task for failing to disclose caveats in their statements?

In this case, anti-smoking groups attempted to take the tobacco industry to task for the failure to provide the proper caveat to the tune of $130 billion. But for us, failing to provide proper caveats is simply, we are told, an acceptable way of doing business.

I think Luik is right when he argues that what these anti-smoking leaders are saying is that lying is OK if it is done for a good purpose. We've already established that many anti-smoking groups are not telling the truth. The real issue for the movement, it appears, is whether this means (being dishonest with the public) is justified by the good ends of decreasing morbidity and mortality from tobacco products.

When all is said and done, what this "internal squabble" comes down to is the question of whether the ends justifies the means. Is dishonesty in public health communications justified by advancement of public health policies?

I say no. We need to adhere to a basic set of ethical principles.

Friday, February 22, 2008

Tobacco Reporter Highlights My New Center for Public Accountability in Tobacco Control Web Site

An article in the February issue of Tobacco Reporter highlights my new web site for the Center for Public Accountability in Tobacco Control (access to the article is free, but you must register first).

The article, entitled "New Center Promotes Integrity in Tobacco Control," states: "Professor Michael Siegel of the Social and Behavioral Sciences Department at the Boston University School of Public Health has established an organization to ensure the ethical and honest practice of tobacco control by anti-smoking organizations in the United States. The Center for Public Accountability in Tobacco Control (CPATC) aims to help ensure that efforts to reduce tobacco-related morbidity and mortality are sustainable by a movement that can remain credible and effective into the future. Its premise is that the anti-smoking movement is going too far in its agenda and losing its solid public health basis. The CPATC hopes to highlight the tactics currently being used in order to hold public health groups accountable to their primary constituency, the public."

The Rest of the Story

I am grateful for this publicity from Tobacco Reporter. I hope this will bring many more visitors to the site to read about the ways in which I believe the tobacco control movement needs to be more accountable to basic principles of public health practice, the ways in which the movement is violating ethical principles, and the ways in which the movement is just going too far. Ultimately, I want the truth to reach the public, because that is the party to which the movement is accountable.

Thursday, February 21, 2008

FDA Tobacco Legislation Supporters Are Using Disingenuous Statements to Promote Policy: Senator Durbin Leads Charge in Deceiving the American Public

According to an article in today's Chicago Tribune, Senator Dick Durbin of Illinois - one of the leading sponsors of proposed legislation that would give the Food and Drug Administration (FDA) limited regulatory authority over tobacco products - is claiming that the strength of the Big Tobacco lobby is what is likely to hold up passage of the legislation.

According to the article: "The measure currently has 56 backers in the Senate, but needs at least 60 to win Senate approval, Durbin said. A similar bill in the House has the support of 215 representatives. Durbin anticipates a fierce battle getting the measure signed into law. "The tobacco lobby is the most powerful on Capitol Hill," Durbin said. "This is a prime example why Washington has to change." Durbin is running for re-election this fall against Republican Steve Sauerberg, a family physician from Willowbrook."

The Rest of the Story

In order to frame this as an issue of public health vs. Big Tobacco, Senator Durbin appears to be trying to convince the American public that Big Tobacco is against this legislation and that all the powerful tobacco companies are using their influence on Capitol Hill to block passage of the legislation.

Unfortunately, nothing could be further from the truth. The company which dominates all the others within Big Tobacco and which is responsible for the lion's share of lobbying expenditures in Congress - Philip Morris - is actually supporting the legislation and lobbying for its passage.

It is, therefore, disingenuous if not downright false to imply that the major reason the bill faces opposition is because of the power of the tobacco lobby. If the tobacco lobby were that powerful, then Philip Morris should easily be able to get this legislation enacted. Obviously, it isn't so simple as that.

But what makes the statement truly disingenuous is that it implies tobacco companies are uniformly opposed to the legislation, which is false.

It is apparently important for politicians such as Senator Durbin to portray Big Tobacco as uniformly opposing the legislation because he wants to be perceived as fighting this battle against Big Tobacco. The reality, however, is that this bill was negotiated with Philip Morris, it includes a number of key provisions demanded by Philip Morris, and Senator Durbin is standing shoulder-to-shoulder with Philip Morris in promoting this legislation in the halls of Congress.

This is hardly a battle between Senator Durbin and Philip Morris. Instead, it is a prime example of a politician who is helping do Philip Morris' bidding on Capitol Hill. Senator Durbin could not possibly be more friendly to the nation's leading tobacco company than to help it lobby for the legislation that it so deeply desires.

That's the truth. That's the rest of the story.

I have no issue with Senator Durbin promoting this legislation. If he wants to hand Philip Morris its dream-come-true and institutionalize into the federal government the approval and acceptance of the death and destruction caused by tobacco products, that's his business. But don't tell me that what he's doing is fighting Philip Morris and Big Tobacco. Don't mislead the American people into thinking that all the major tobacco companies oppose this legislation.

I think the American public deserves something better.

Something called ...

... the truth.

Wednesday, February 20, 2008

Anti-Smoking Group Asserts that Physicians are Killing 40,000 U.S. Smokers per Year

According to the national anti-smoking group ASH (Action on Smoking and Health), U.S. physicians are "killing more than 40,000 American smokers each year." This killing is occurring, according to ASH, because physicians are failing to advise their patients to quit smoking and to offer appropriate medication or other smoking cessation services.

According to the ASH statement:

"Public interest law professor John Banzhaf ... has written to the health commissioners of the fifty states suggesting that they warn their state's doctors about such [malpractice] law suits based upon a recent article in a leading medical journal and an even more recent study about saving smoker lives. The letter notes a recent study which shows that physicians are killing more than 40,000 American smokers each year by failing to follow federal guidelines which mandate that the doctor warn the patient about the many dangers of smoking and provide effective medical treatment for the majority who wish to quit."

The Rest of the Story

I think it is really going too far to state that physicians are killing their patients. It is one thing to note that the failure to advise patients to quit and to provide them with smoking cessation services results in more than 40,000 smokers dying each year (let's stipulate, for the sake of discussion, that this is correct). But it is quite another to assert that these physicians are killing their patients.

Just because someone fails to do something which could prevent a death, it doesn't mean that he has killed that person. Killing is generally viewed as an act of commission, not as one of omission. Perhaps in extreme situations of neglect of a dying person, one might make an argument that someone has killed another individual. But this hardly represents that kind of extreme neglect.

Of note, the report itself does not assert that physicians are killing their patients. This is language that is attributable solely to ASH. If I were the organizations that issued the report, I would be angry at ASH for misrepresenting my report and for implying that I had made such an assertion.

It really doesn't say a lot about the current state of the anti-smoking movement that it is accusing physicians of killing their smoking patients. This simply goes to further undermine the credibility of the movement. If the movement goes out and claims that physicians are killing 40,000 smokers each year, who is going to listen to the movement when it makes claims that really are valid? It is a disservice to the movement to undermine its credibility like this.

Moreover, I find it quite disrespectful of physicians. Sure, they [we] may not be the perfect deliverers of preventive medical care, but the lack of time that physicians have to deliver such care hardly makes the failure to provide smoking cessation services the equivalent of killing their patients.

Tuesday, February 19, 2008

Mishegas: Action on Smoking and Health Supporting Proposals to License Smokers and Sue Physicians

Their proposals may not make any sense, but you have to admit that ASH has a lot of chutzpah. Don't miss today's discussion of ASH's proposals to: (1) ask state health commissioners to threaten physicians with malpractice lawsuits if they don't prescribe smoking cessation drugs for their patients; and (2) require licenses for smokers to purchase cigarettes.

Licensed to Smoke: ASH Supports Proposal to Require License to Purchase Tobacco Products

According to a press release issued by Action on Smoking and Health (ASH), the group is supporting a proposal that would require smokers in the UK to obtain a license in order to purchase tobacco products. ASH is not only supporting the proposal, but is actually working to strengthen it by increasing the requirements that must be met in order to obtain a license to smoke.

First, ASH wants, as a condition of obtaining a license to smoke, that applicants read and sign a document indicating that they understand all the health effects of secondhand smoke. Notably, that information would include the "fact" that "exposure for as little as thirty minutes can trigger a fatal heart attack in adults."

Second, ASH wants, as an additional condition of obtaining a license to smoke, that applicants "thoroughly understand all of the health and financial consequences to themselves of continuing to smoke, and that they are willing to accept these risks and burdens."

Third, ASH wants applicants to be "required to review information about various cessation techniques and cessation programs (especially those available in their area), including various forms of pharmacological intervention."

Fourth, ASH wants applicants to be "required to provide a form signed by a physician or other appropriate health professional certifying that whatever tests are appropriate for someone with the heightened health risks caused by smoking (e.g., a chest X-ray every 5 years after the age of 40, etc.) had been performed, and the smoker had been advised of the results of the tests."

The Rest of the Story

I think this is a splendid proposal.

But since it is such a great idea, I think we ought to extend it to other health behaviors as well.

So first, I would like to propose that anyone wishing to drink alcohol must obtain a license in order to purchase alcohol. Before obtaining such a license, the applicant should be required to articulate the health effects of alcohol, including its effects on liver function, brain cells, cancer risk, and the gastrointestinal mucosa. The person must also sign a statement indicating that he understands all the risks and financial consequences of drinking, and is affirmatively choosing to take such risks. I think the person should be required to submit a signed affadavit, notarized by a public notary, that no other person is coercing or otherwise exerting undue influence on that person's decision to drink alcohol. I believe the person should also be required to have liver function tests to make sure that his or her liver isn't already shot, to have a liver scan to detect any potential carcinogenic lesions, and to have an upper endoscopy - both to rule out esophageal cancer and to screen for ulcers, which may be caused by or exacerbated by drinking.

Second, I would like to propose that anyone wishing to eat trans-fats should be required to obtain a license to purchase products containing trans-fats. All grocery stores could be equipped with technology that would quickly determine if any given product contains trans-fats. This information could easily be obtained from the product's bar code. If trans-fats are contained in a product, the grocery clerk would be alerted and would demand that the customer provide a trans-fat consumption license. To maintain such a license, the person would have to take a renewal test every five years, with questions on the latest epidemiologic data on the risks of trans-fat consumption.

Third, I would like to propose that anyone wishing to engage in sex be required to purchase a license. While many people would not do so, the law could be changed so that in the case of a person obtaining an STD, the failure of the partner to have obtained a license would be grounds for compensation of the victim by that individual. Applicants for these licenses would be given courses on HIV/AIDS, syphilis, human papillomavirus, and other agents known to be responsible for the sexual transmission of disease. They would also be required to undergo a physical examination and screening for current STD's. To protect privacy, any applicant could request a same-sex examiner and screener.

Despite the highly sensible approach being suggested by ASH, I do have a few concerns.

First, what if it is the case that only 5 minutes of secondhand smoke exposure causes heart attacks, as claimed by one anti-smoking group? Wouldn't telling people that it takes a whole 30 minutes then be deceptive? Wouldn't people take it too lightly?

Since one anti-smoking group has claimed that just 30 seconds of tobacco smoke exposure is as bad as a lifetime of active smoking in terms of impaired coronary artery function, I have the same problem with telling people that 5 minutes of secondhand smoke causes heart attacks. I think we'd have to get it down to at least 30 seconds, if not lower.

Second, people may claim to understand the financial consequences of smoking, but without really understanding financial accounting, can we really expect them to be able to predict the effect of their smoking on their future financial status? At a minimum, I think smokers should be required to complete a course on financial accounting before obtaining a license to smoke.

Third, since people are going to be made aware of various forms of pharmacologic treatment available to help smokers quit, I'm a little concerned that smoking license applicants might actually be informed about the suicide risks associated with Chantix, and might therefore might not be as receptive to it as they might otherwise be. I would like to see a clause in this legislation that excuses the licensing organization from revealing the full information about the risks of Chantix. The staff of the orgnanization should be provided with full legal immunity in the case someone takes Chantix as a result of their being informed of the available pharmacologic therapies and ends up committing suicide as a result.

Finally, since ASH is asking for required medical testing that has been clearly deemed inappropriate by every major medical body that has considered the issue (i.e., chest x-ray screeening every 5 years after age 40), I would like to add some ill-advised medical tests of my own. Why not simply require a whole-body CT scan? I see no reason to leave any body part untouched.

ASH Asks State Health Commissioners to Threaten Physicians with Malpractice Suits for Failure to Prescribe Pharmaceutical Therapy for Smokers

The national anti-smoking group Action on Smoking and Health (ASH) has written to the state health commissioners, asking them to threaten physicians in their states with malpractice suits if they fail to follow national smoking cessation guidelines, which require the use of pharmaceutical therapy for all patients.

A February 11 press release from ASH states: "Public interest law professor John Banzhaf, who the media has dubbed a "driving force behind the lawsuits that have cost tobacco companies billions of dollars," and the "law professor who masterminded litigation against the tobacco industry," has written to the health commissioners of the fifty states suggesting that they warn their state's doctors about such law suits based upon a recent article in a leading medical journal and an even more recent study about saving smoker lives. The letter notes a recent study which shows that physicians are killing more than 40,000 American smokers each year by failing to follow federal guidelines which mandate that the doctor warn the patient about the many dangers of smoking and provide effective medical treatment for the majority who wish to quit. 'The families of any one of those 40,000 victims - or the hundreds of thousands more who suffer heart attacks, strokes, amputations, blindness, or other problems because of their smoking - could sue physicians for malpractice for failing to follow the standard of medical care mandated by these guidelines,' says Banzhaf."

The Rest of the Story

There are a lot of problems with this action by ASH, not the least of which is that it threatens physicians with bogus lawsuits and that it threatens to tie up the courts with frivolous litigation.

To cut to the chase, there is no valid legal basis for the threatened lawsuits, because in order to prove malpractice, a plaintiff would have to show that the disease in question would not have occurred had the physician followed the clinical practice guidelines. In other words, the smoker would have to show that had only the physician prescribed some sort of pharmaceutical therapy, he would have successfully quit smoking and had he quit smoking, he would not have suffered the disease.

The first showing is impossible, however, because the data clearly show that the overwhelming majority of patients who are treated with pharmaceuticals for smoking cessation are not successful in quitting.

In court, a smoker would have to show that it is more likely than not that had he received the pharmacotherapy as outlined by the clinical practice guideline, he would have successfully quit smoking. This means that there would have to be greater than a 50% success rate for this therapy. Unfortunately, the success rate for pharmacotherapy is much worse, on the order of only 10% (and that is in the setting of clinical trials).

While it could, potentially, be considered negligent for a physician not to warn his or her patient to quit smoking, the plaintiff cannot win such a malpractice case unless he shows that the failure to give the advice was what caused the injury. The injury is not the smoking, but the illness or disease that allegedly resulted from the smoking.

Remember that the risk of the disease in question is not inherently and directly related to the provision of advice to quit smoking. Instead, it is inherently and directly related to the patient's behavior - smoking. Thus, the damages are directly tied only to the patient's actions, not the physician's actions.

The connection between the purported damages and the physician's action are indirect. The postulated link is that the physician's action could have changed the patient's behavior, which in turn could have prevented the injury. Thus, to support both of the links in this purported causal chain, the plaintiff would have to show that the physician's action would, more likely than not, have changed the patient's behavior.

This cannot be shown unless there is evidence that intervention by the physician can result in a greater than 50% smoking cessation rate. I assure my readers that I am familiar with the literature on smoking cessation and the role of physician advice and there is no evidence that the success of physician intervention is anything close to 50%. In reality, it is probably a lot closer to about 6%.

Is pursuing baseless lawsuits and threatening physicians with them really what the tobacco control movement wants to be doing?

The rest of the story, it appears, is that the answer is yes.

Thursday, February 14, 2008

New Study Concludes that Italian Smoking Ban Reduced Heart Attack Rates Within First Year

An article published online ahead of print in the journal Circulation concludes that the ban on smoking in public places in Italy has resulted in an 8%-11% decline in acute coronary events (i.e., heart attacks) in the first year following implementation of the ban (see: Cesaroni G, Forastiere F, Agabiti N, et al. Effect of the Italian Smoking Ban on Population Rates of Acute Coronary Events. Circulation 2008).

The study compared the annual age-standardized rates of acute coronary events among adults in three different age groups during the five years preceding the smoking ban (2000-2004) to the rates during the first year the ban was in effect (2005). The post-smoking ban acute coronary event rate was 11% lower than the pre-ban rate for adults ages 35-64 and 8% lower for adults ages 65-74. There was no significant difference in the pre- and post-ban rates for adults ages 75-84.

The authors conclude that the observed reduction in the heart attack rate in 2005 among 35-74 year-olds was atributable to the smoking ban. Furthermore, the authors conclude that at least a portion of the effect is due to a reduction in secondhand smoke exposure among nonsmokers.

One study author stated: "Smoking bans in all public and workplaces result in an important reduction of acute coronary events."

These conclusions have been widely reported. For example, this article was headlined: "Public smoking ban decreases acute coronary events in Italy."

Results of this and related studies (with similar methodology) are being used by anti-smoking advocates in testimony before policy makers that smoking bans have an immediate effect on heart attack rates.

The Rest of the Story

There's just one problem with all of this: the conclusions of this study are not supported by the data. The data clearly show that the decline in heart attack rates among adults in these two age groups began prior to the implementation of the smoking ban. Thus, it is evident that the decline is not attributable to the smoking ban.

Take a look at the data for yourself:

A. Age 65-74

From 2003 to 2004 (prior to the smoking ban), the heart attack rate declined from 7.86 to 7.39, a drop of 6.0%.

From 2004 to 2005 (first year of the smoking ban), the heart attack rate declined from 7.39 to 6.95, a drop of 6.0%.

In other words, the decline in the heart attack rate from 2003 to 2004 was exactly the same as the decline from 2004 to 2005.

These data clearly do not support the conclusion that the smoking ban resulted in a sudden drop in the heart attack rate. Instead, these data document that the decline in the heart attack rate in this age group was exactly the same post-ban as it was pre-ban.

In light of these data, I find it impossible and highly invalid to conclude that the smoking ban resulted in the observed decline in heart attacks from 2004 to 2005. A more likely, and certainly plausible, explanation is that there was already a trend of declining heart attack rates and that this trend simply continued from 2004 to 2005.

The precise reasoning being used by this paper could equally be used to argue that the smoking ban had no effect on heart attacks. I'm not making such a claim, but I am suggesting that these data by no means support the conclusion of the article. In fact, they refute such a conclusion.

B. Age 35-64

From 2002 to 2003 (prior to the smoking ban), the heart attack rate declined from 2.13 to 1.95, a drop of 8.5%.

From 2004 to 2005 (the first year of the smoking ban), the heart attack rate declined from 1.92 to 1.80, a drop of 6.3%.

In other words, the observed decline in the heart attack rate one year prior to the smoking ban was actually greater than the decline in the heart attack rate after the smoking ban.

The average decline in the heart attack rate for the two year period preceding the smoking ban (2002 to 2004) was 4.9%.

The decline in the heart attack rate for the first year following the smoking ban was 6.4%.

Thus, one can see that the decline in the heart attack rate in this age group after the smoking ban was comparable to the decline in the heart attack rate in this age group before the smoking ban.

Once again, these data clearly do not support the conclusion that the smoking ban resulted in a sudden drop in the heart attack rate. If anything, these data document that the decline in the heart attack rate in this age group was about the same post-ban as it was pre-ban.

In light of these data, I find it impossible and highly invalid to conclude that the smoking ban resulted in the observed decline in heart attacks from 2004 to 2005. A more likely, and certainly plausible, explanation is that there was already a trend of declining heart attack rates and that this trend simply continued from 2004 to 2005.

The precise reasoning being used by this paper could equally be used to argue that the smoking ban had no effect on heart attacks. Again, I'm not making such a claim, but I am suggesting that these data by no means support the conclusion of the article. In fact, they refute such a conclusion.

What is so alarming about the conclusion of this Italian smoking ban study is not so much that the authors have drawn a conclusion that follows from the data but have failed to consider alternative explanations for the cause of the decline in heart attack rates. What is so alarming is that they have drawn a conclusion that is completely unsupported by the data itself.

In other words, what appears to be operating here is an investigator bias, by which the authors seem to have been determined to find an effect even if one did not exist. It appears that this bias probably skewed their judgment in evaluating these data.

If you want to see what I mean, plot the heart attack rates for yourself on a graph. I used Microsoft Excel to do this and it took just a few minutes.

Then, examine the trend in heart attack rates among the age groups visually. For the 35-64 year-old group, you will readily see that there is literally a straight line from 2002 to 2005. There is an apparent decline in the heart attack rate that has remained relatively stable during the past few years. But that decline started in 2002, not in 2004.

Similarly, if you look at the graph for the 65-74 year-old group, you will see that there is literally a straight line from 2003 to 2005. There is indeed a trend of a declining heart attack rate, but that decline starts in 2003.

The appropriate conclusion from these data is that there is indeed a significant decline in the heart attack rates among 35-74 year-olds, but that this decline preceded the implementation of the smoking ban. The smoking ban certainly does not seem to have done anything to alter the existing observed declines.

This does not prove that the smoking ban had no effect. But what it does is indicate that the conclusion of the study is completely invalid.

There is another serious problem which, independently of the improperly interpreted data, renders the study conclusion invalid. That problem is simple: there is no comparison group. Without a comparison group, it is impossible to know whether the observed changes in heart attack rates in Italy are unique to Italy or whether they mirror similar secular changes occurring elsewhere.

We happen to know, for example, that in the United States, there have been substantial declines in heart attack rates - even in states without smoking bans - during the same time period. There is no way that the study can conclude that the observed decline in Italy is not simply a reflection of the underlying secular trend of declining coronary event rates that is occurring anyway, even in the absence of the smoking ban.

What I find highly intriguing is the apparent bias that is plaguing the interpretation of these smoking ban/heart attack studies, from Helena to Pueblo to Saskatoon to Bowling Green to Ireland to Scotland to Piedmont to Rome.

What I think this shows is that if one wants strongly enough to be able to find an effect of something, that can skew ones interpretation and analysis of the data such that one is able to do so. That is somewhat reasonable, since there is always going to be an inherent bias in any scientific study.

But what is not so reasonable to me is that these inherent biases and the skewed and invalid interpretation of the data are not being picked up by journals. It suggests that perhaps the peer reviewers who are being chosen to review these studies are affected by the same bias. If these papers are not being reviewed by scientists who are neutral, then those reviewers are far less likely to pick up the glaring flaws in these study conclusions. It certainly appears that may have been what happened in the case of Rome.

Tuesday, February 12, 2008

Anti-Smoking Group Which Defends Calabasas Apartment Smoking Ordinance is Deceiving Itself

In a response to my letter to the editor published last week in The Acorn in which I criticized the Calabasas apartment smoking ordinance, the anti-smoking group “SAFE” published a letter which attempted to refute my argument against the ordinance by suggesting that the law will require 80% of apartment buildings to be smoke-free, and thus will provide protection for a large proportion of nonsmokers.

SAFE (Smokefree Air for Everyone) wrote: "In his letter to The Acorn Jan. 31, Michael Siegel asserted that the new smoking regulations recently passed in the city of Calabasas would make life more difficult for the residents in apartments. He could not be more wrong. The city of Calabasas has three apartment complexes, each one consisting of as many as 50 buildings, each building consisting of as many as 16 units. In 2006, the City Council passed an ordinance requiring no smoking in common areas of these apartment complexes, thus forcing tenants back into their apartments to smoke around their loved ones. ... The new ordinance will require 80 percent of the buildings to become non-smoking over time. Current residents who smoke will be permitted to continue smoking in their units until they move. ... Both non-smokers and folks who smoke will benefit from the Calabasas Housing Ordinance. Once again, Michael Siegel is wrong."

The Rest of the Story

There are three major problems with the argument put forward by SAFE.

1. The ordinance does not ban smoking in 80% of apartment buildings.

It is not true that the ordinance bans smoking in 80% of apartment buildings. First of all, the ordinance bans smoking in 80% of apartment units, not 80% of apartment buildings. It does require that the smoking units be placed in the minimum number of buildings, so in effect, it does restrict smoking in many of the buildings, but depending on the number of apartments and units, fewer than 80% of buildings may be smoke-free.

More importantly, the ordinance allows any and all residents to request that their units be designated as smoking units. Thus, in reality, no apartment buildings (ZERO) will be smoke-free. Almost certainly, there will be many residents in all of the apartment buildings who designate their units as smoking units. Therefore, the ordinance, in reality, virtually guarantees that there will not be any smoke-free apartment buildings.

2. While providing protection for many, the ordinance will make the problem much worse for some.

It is true that, over time, apartment buildings which are designated as non-smoking will have lower levels of tobacco smoke. However, the apartment buildings which are designated as smoking will invariably have much higher levels of tobacco smoke. Thus, the nonsmokers living in these buildings will be exposed to much higher levels of secondhand smoke. While there may not have been a problem when the smokers were relatively spread out, there almost certainly will be a problem when the smokers are all congregated in one area.

3. The ordinance takes away recourse for those nonsmokers who are affected by tobacco smoke from neighboring units.

By specifically regulating the allotment of smoking and nonsmoking units, the ordinance takes away any recourse that nonsmokers have to remediate the situation if they are affected by tobacco smoke from neighboring apartments (a problem which is likely to continue since all existing smokers will likely designate their units as smoking). The ordinance even states, specifically, that tobacco smoke entering a neighboring apartment is not a nuisance as long as the landlord is in compliance with the ordinance.

Thus, SAFE can deceive itself all it wants into believing that this ordinance is going to guarantee nonsmokers protection from secondhand smoke, but the reality is that it guarantees protection to nobody, while at the same time denying all nonsmokers the possibility of successfully seeking recourse if they are in fact affected by exposure to tobacco smoke in their homes.

The worst thing about the ordinance is that it sets a bad example for communities throughout the country which are going to consider this issue in the future. If cities in other areas follow this poor model of public health policy, it will result in a public health disaster. Apartment dwellers throughout the country will lose their ability to successfully seek recourse for health effects from secondhand smoke.

Perhaps most importantly, because it fails to guarantee any health protection for anyone, and because it achieves public health gains for some at the expense of others, I think it is an example of unwarranted government intrusion into the way that landlords operate their businesses. It is difficult to defend an intrusive policy such as this one under these conditions.

Monday, February 04, 2008

District Court Judge: Smoker's Lawsuit Against The Scotts Company for Employment Discrimination May Proceed on Grounds of Invasion of Privacy

A U.S. District Court judge for the District of Massachusetts ruled last week that there are sufficient legal grounds for a lawsuit filed by a smoker against The Scotts Company to proceed. The plaintiff - Scott Rodrigues of Bourne, Massachusetts - was fired by Scotts after failing a urine cotinine test.

The company instituted a new policy in December 2005 by which it fires smokers. At the time the policy was announced, employees were given one year to quit smoking completely or be fired. Scott Rodrigues claimed that he was fired from a job with Scotts that he held for just a few weeks after a required urine cotinine test turned up positive for cotinine. As I reported here in December 2006, Rodrigues filed a lawsuit against the company, claiming that the company unduly violated his privacy and civil rights. The suit was filed primarily under Massachusetts privacy law, which "bars the unreasonable, substantial or serious interference of privacy."

The District Court ruled that there are sufficient grounds to proceed with the case to determine whether Rodrigues' firing violated Massachusetts privacy law. It also found that the suit may proceed based on a second legal claim: that Scotts violated ERISA (Employee Retirement Income Security Act) by interfering with his attainment of benefits for which he would have been eligible if not for having been fired.

The District Court did dismiss two of the legal grounds in the case: it ruled that the case cannot proceed on the basis that Scotts violated the Massachusetts Civil Rights Act or that Rodrigues was wrongfully terminated under Massachusetts common law.

The case will now proceed to the discovery phase on the privacy and ERISA claims.

The Rest of the Story

As I opined last December, the meat of this lawsuit is really the privacy contention.

The common law claim was never going to go anywhere, since Massachusetts has at-will employment and the firing did not fit into any category protected under federal or state law. The Massachusetts Civil Rights Act claim was also very weak.

In addition, I believe that the ERISA complaint will be quickly dispensed with, since it requires that it be shown that the employer specifically fired Rodrigues in order to interfere with his attainment of ERISA benefits, which is quite clearly not the case (although Judge O'Toole ruled that the facts need to be formally presented and litigated).

The invasion of privacy complaint, however, may well have legal merit. As Judge O'Toole points out: "Section 1B of Chapter 214 of the Massachusetts General Laws provides: “A person shall
have a right against unreasonable, substantial or serious interference with his privacy.” The right is broadly stated and it has been left to the courts to determine its scope. It has been held that the statute “proscribe[s] the required disclosure of facts about an individual that are of a highly personal or intimate nature when there exists no legitimate, countervailing interest.”

The lawyers for Scotts will argue that the company's interest in saving health care costs by not hiring smokers outweighs the interference with privacy entailed by requiring a prospective employee to submit to a urine cotinine test. However, my personal feeling is that there is simply no relationship between an employee's smoking status and his or her bona fide qualifications for employment with the Scotts Company. Thus, in my mind, the countervailing interest in this case is not legitimate, or at least, it does not outweigh the invasion of privacy regarding the lawful conduct of the employee in the privacy of his or her own home.

A ruling in Scotts' favor would open the door to all kinds of intrusive medical testing of prospective employees that has no relationship to bona fide job qualifications. If saving health care costs is found to be a large enough countervailing interest to justify intrusive medical procedures that require testing of bodily fluids, then all kinds of other intrusive medical testing are justified, not only cotinine testing.

For example, how about requiring diabetics to submit to a hemoglobin A1C blood test to make sure that their blood sugar is under control? How about requiring people at high risk of sexually transmitted diseases to provide specimens for testing to make sure they are not infected with various microbial agents? How about requiring female employees to submit to an HPV test to make sure they are not at risk for cervical cancer?

Now of course such tests would be precluded under the Americans with Disabilities Act. However, that fact alone does not alter the balancing equation that should be employed here. If not for the ADA, this type of testing would indeed be legitimate if the Court rules that an employer's interest in controlling health care costs is sufficient to require intrusive bodily testing.

One final point that I think is critical. Scotts will likely argue that Scotts has a legitimate business interest in not hiring smokers, in that smoking affects business productivity. However, it can hardly be argued that health care costs are related to business productivity. Some of the most productive workers, namely young people with children, have the highest health care costs because their children make them sick so often. Moreover, while smoking in the workplace has been shown to relate to business productivity, Scotts' policy is not to ban smoking in the workplace, but to ban smokers. I'm aware of no evidence that a smoker, per se, is less productive (having dismissed the issue of taking smoking breaks on the job, since if Scotts' interest were in preventing smoking breaks on the job, the company could simply prohibit smoking breaks on the job).

I think the key to the case will be arguing that health care costs must be considered separately from business productivity, and that the degree of intrusion of privacy that is legitimate in terms of protecting business productivity is far higher than what is legitimate in terms of protecting a business' health care costs.

This would be my argument were I presenting to the District Court. I will report back when any ruling is issued in the case.